Pulmonary Vein Stenosis After Catheter Ablation of Atrial Fibrillation Using a Cryoballoon, Hot Balloon, or Laser Balloon.

BACKGROUND: Pulmonary vein stenosis (PVS) after PV isolation (PVI) for atrial fibrillation (AF) is a severe complication that requires angioplasty. This study aimed to compare the reduction of the cross-sectional PV area (PVA) and the incidence of PVS after cryoballoon (CB)-PVI, hot balloon (HB)-PVI, or laser balloon (LB)-PVI.Methods and Results: A total of 320 patients who underwent an initial catheter ablation procedure for AF using a CB, HB, or LB in 2 hospitals were included. They underwent contrast-enhanced multidetector CT before and 3 months after the procedure. In all 4 PVs, the reduction in PVA was more significant in the LB group than in the CB or HB groups, respectively. Moderate (50-75%) and severe (>75%) PVS were observed in 5.3% and 0.5% of the PVs, respectively. Although moderate PVS was more frequently observed in the LB group than in the CB or HB groups (8.2%, 3.8%, and 5.0%; P=0.03), the incidence of severe PVS was similar in the LB, CB, and HB groups (0.3%, 0.5%, and 1.0%; P=0.46). Symptomatic PVS requiring intervention occurred in 1 (0.3%) patient. CONCLUSIONS: Although the reduction in cross-sectional PVA and the incidence of moderate PVS after LB-PVI was more significant than after CB-PVI or HB-PVI, it rarely led to severe PVS. Symptomatic PVS requiring intervention was rare after the balloon ablation of AF.

Using the pre-freezing technique results in a wider area of antral isolation during cryoballoon pulmonary vein isolation in patients with atrial fibrillation.

The "pre-freezing" technique was a method in which a fully inflated balloon after the start of freezing was pressed against the pulmonary vein (PV) during cryoballoon ablation and has been applied especially in large-size PVs. Of 556 patients who underwent cryoballoon ablation for atrial fibrillation (AF), the pre-freezing technique was applied to 48 patients. The resulting 2:1 propensity score-matched data set included 120 patients. Using the pre-freezing technique, all left-superior PVs, all left-inferior PVs, and 95% of right-superior PVs were successfully isolated. In most right-inferior PVs, complete sealing using the pre-freezing technique was challenging, and this technique was not applied. Procedure time was similar between the two groups. In the pre-freezing group, the percentage of the left atrial posterior wall isolated was larger (47.6 ± 10.3 vs. 42.8 ± 15.7%, P = 0.006), and the postoperative reduction of diaphragmatic compound motor action potentials tended to occur less frequently (2.5 vs. 12.5%, P = 0.07), and the reduction of the cross-sectional LSPV area was smaller (17.5 ± 12.2 vs. 27.2 ± 19.8%, P = 0.03) than the conventional group. The AF-free rate of the two groups was similar between the two groups (P = 0.15). The pre-freezing technique was a simple method that can isolate a wider surface area during cryoballoon PV isolation. While the postoperative AF recurrence was comparable, the postoperative reduction in the cross-sectional PV area was less than that of the conventional method, which may reduce the risk of PV stenosis.

A 15-year follow-up study of radiofrequency catheter ablation for atrial fibrillation in patients with tachycardia-bradycardia syndrome.

INTRODUCTION: Catheter ablation for atrial fibrillation (AF) in patients with tachycardia-bradycardia syndrome (TBS) can be a major therapeutic option to replace permanent pacemaker implantation (PMI). However, the very long-term outcome of more than 15 years in these patients has not been elucidated. METHODS: From 2002 to 2008, 25 consecutive TBS patients (62 ± 7.9 years old, 68% male) with both AF and symptomatic sinus pauses (>3.0 s) were performed radiofrequency AF ablation. These patients were followed for 15 ± 2.7 years. RESULTS: The median longest sinus pause before the ablation procedure was 6.0 s (4.4-8.0). Following 1.6± 0.8 ablation procedures, 18 (72%) patients remained free from AF. Three (12%) patients died due to noncardiovascular causes, and seven (28%) patients underwent PMI due to symptomatic sinus pause after recurrent AF in five patients and progression of sinus node dysfunction in two patients. The median duration from the first AF ablation to PMI was 6.3 years (range: 9 days to 11.0 years). Five and two patients required PMI more than 5 and 10 years after the first ablation procedure, respectively. CONCLUSION: AF ablation prevented PMI in 72% of TBS patients for a 15-year follow-up. However, in consideration of the long duration of PMI, a continuous careful long-term follow-up was warranted.

HeartMate 3: new challenges in ventricular tachycardia ablation.

AIM: To describe clinical characteristics, procedural details, specific challenges, and outcomes in patients with HeartMate3™ (HM3), a left ventricular assist device system with a magnetically levitated pump, undergoing ventricular tachycardia ablation (VTA). METHODS AND RESULTS: Data were collected from patients with an HM3 system who underwent VTA in seven tertiary centres. Data included baseline patient characteristics, procedural data, mortality, and arrhythmia-free survival. The study cohort included 19 patients with cardiomyopathy presenting with ventricular tachycardia (VT) (53% with VT storm). Ventricular tachycardias were induced in 89% of patients and a total of 41 VTs were observed. Severe electromagnetic interference was present on the surface electrocardiogram. Hence, VT localization required analysis of intra-cardiac signals or the use of filter in the 40-20 Hz range. The large house pump HM3 design obscured the cannula inflow and therefore multi imaging modalities were necessary to avoid catheter entrapment in the cannula. A total of 32 VTs were mapped and were successfully ablated (31% to the anterior wall, 38% to the septum and only 9% to the inflow cannula region). Non-inducibility of any VT was reached in 11 patients (58%). Over a follow-up of 429 (interquartile range 101-692) days, 5 (26%) patients underwent a redo VT ablation due to recurrent VTA and 2 (11%) patients died. CONCLUSIONS: Ventricular tachycardia ablation in patients with HM3 is feasible and safe when done in the appropriate setup. Long-term arrhythmia-free survival is acceptable but not well predicted by non-inducibility at the end of the procedure.

Transition of the heart rate and atrial premature complex after cryoballoon vs. radiofrequency ablation for paroxysmal atrial fibrillation.

The temporal changes in ambulatory monitoring findings after cryoballoon (CB) ablation of atrial fibrillation (AF) have not been well elucidated. This study aims to compare the details of ambulatory monitoring after CB and radiofrequency catheter (RFC) ablation for AF. Of 724 consecutive AF patients who underwent initial ablation using a CB or RFC, 508 (254 pairs) were selected using propensity score matching. Ambulatory monitoring was performed at 1, 3, 6, 12, 24 and 36 months after the procedure. After 1, 3 and 6 months, the number of total heart beats (THBs) was larger in the CB group than in the RFC group. It gradually decreased and became significantly similar by 12 months after ablation. THBs significantly increased 1, 3, 6 and 12 months after ablation in both the RFC and CB groups and became statistically similar by 24 months after ablation. The atrial premature contraction burden was higher in the RFC group than in the CB group at 3 months after ablation. THB and APC burden after AF ablation were significantly different between the RF and CB groups. THBs returned to statistically similarity by 2 years after ablation in both groups.

Comparison of atrial arrhythmia recurrence after persistent atrial fibrillation ablation between patients with or without tachycardia-induced cardiomyopathy.

BACKGROUND: The presence of heart failure (HF) has been associated with poorer outcomes in patients undergoing catheter ablation (CA) for atrial fibrillation (AF). However, the effectiveness of CA amongst the subset of patients with tachycardia-induced cardiomyopathy (TIC) remains poorly defined. METHODS AND RESULTS: In a retrospective analysis we compared outcomes of first-time CA for persistent AF in a cohort of patients with previously diagnosed TIC (n = 45; age 58 ± 8 years; 91% male) to those with structurally normal hearts (non-TIC; n = 440; age 55 ± 9 years; 95% male). TIC was defined as an impaired ventricular function (left ventricular ejection function [LVEF] <50%), which was reversed after the treatment of HF. We compared atrial arrhythmias (AAs) recurrence after the CA in the TIC and non-TIC cohorts. In the TIC group, LVEF improved from 35.8% ± 8.1% to 57.5% ± 8.3% after treatment of HF. During 3.3 ± 1.5 years follow-up, AAs-free survival after CA was significantly higher in the TIC group as compared with the non-TIC group (69% vs 42%; P = .001), despite a comparable CA strategy between the two groups. In multivariable analysis, absence of HF with TIC, longer AF duration, and complex fractionated atrial electrogram ablation were independent predictors of arrhythmia recurrence (OR, 1.02; 95% CI, 1.01-1.03; P < .01; OR, 0.40; 95% CI, 0.20-0.79; P < .01 and OR, 2.29; 95%CI; 1.27-4.11; P < .01, respectively). In addition, the outcome after the last procedure was superior in the TIC cohort (89% vs 72%; P = .03) with fewer CA procedures as compared with the non-TIC cohort (1.3 ± 0.5 vs 1.5 ± 0.7; P = .01). CONCLUSIONS: Persistent patients with AF with TIC have a more favorable outcome after the CA as compared with those without.

Pulmonary vein re-mapping after cryoballoon ablation for atrial fibrillation.

Aims: Establishment of pulmonary vein isolation (PVI) during cryoballoon (CB) ablation is generally confirmed by use of an octapolar inner-lumen mapping catheter (Achieve®). The aim of this study is to evaluate the residual PV potential (PVP) using the conventional circular catheter after CB-PVI. Methods and results: A total of 105 consecutive patients (418 PVs) with paroxysmal AF who underwent the initial CB-PVI were prospectively included in this study. Of those, 305 (73%) PVs with real-time recordings of PVP elimination by Achieve® catheter during successful PVI were included. After isolation of all 4 PVs, PV antral remapping by conventional circular mapping catheter was performed. After CB-PVI, residual PVP was detected in 4.3% (13/305) of PVs (1.2% of left-superior PV, 2.5% of left-inferior PV, none of right-superior PV, and 20% of right-inferior PV). Almost 60% of residual PV potential was located around the bottom portion of the right-inferior PV. In PVs with residual potential, PV trunk was shorter (12.7 ± 5.7 mm vs. 18.7 ± 7.9, P = 0.001), minimal balloon temperature was higher (-46.6 ± 5.9 °C vs. -50.9 ± 8.2, P = 0.02), and balloon warming time was shorter (35.6 ± 17.8 s vs. 50.0 ± 22.8, P = 0.006) than those without. All residual potentials were eliminated by additional touch up ablation. After the initial ablation procedure, 1-year AF-free rate was 79.5%. Conclusion: PV remapping after CB-PVI revealed residual antral PVP in 4.3% of PVs and in 20% of RIPVs in particular. The Achieve® catheter sometimes fails to detect complete PV antral isolation.

Dissociated pulmonary vein activity after cryoballoon ablation and radiofrequency ablation for atrial fibrillation: a propensity score-matched analysis.

Cryoballoons (CBs) have proven to be effective for achieving pulmonary vein isolation (PVI) in patients with atrial fibrillation (AF). Dissociated PV activity (DPVA) after successful radiofrequency PVI is sometimes observed inside the PV and has been found to prove the achievement of electrical disconnection from the left atrium. However, little is known about the incidence or characteristics of DPVA after CB-PVI. The aim of this study was to compare the incidence and characteristics of DPVA in patients undergoing CB and radiofrequency (RF) ablation for AF. Two hundred and ninety-four propensity score-matched patients from 440 consecutive patients who underwent initial catheter ablation for paroxysmal AF were included in the present study (CB-PVI 147, RF-PVI 147). DPVA was more frequently observed after CB-PVI than after RF-PVI (32 vs. 19% of the PVs, P < 0.001), especially in the left superior PV (52 vs. 29%, P < 0.001) and left inferior PV (22 vs. 7%, P < 0.001). The AF-free rate after the initial ablation in the patients with and without DPVA was similar in both the CB (P = 0.23) and RF (P = 0.39) groups. During repeat ablation procedures for recurrent AF, PV reconnection was similarly observed in PVs with and without DPVA during the initial procedure, both in the CB (30 vs. 44%, P = 0.29) and RF (65 vs. 58%, P = 0.41) groups. DPVA was more frequently observed after CB-PVI than after RF-PVI. The presence of DPVA was not related to the ablation outcome or chronic PV reconnection following CB-PVI.

Radiofrequency needle for transseptal puncture is associated with lower incidence of thromboembolism during catheter ablation of atrial fibrillation: propensity score-matched analysis.

Atrial fibrillation (AF) ablation requires transseptal puncture to access the left atrium. Recently, a radiofrequency (RF) needle was developed. The purpose of this study was to compare the incidence of MRI-confirmed acute cerebral embolism (ACE) during AF ablation procedures performed with RF needle versus mechanical needle transseptal puncture. This study consisted of 383 consecutive patients who underwent catheter ablation for AF that required transseptal puncture with mechanical or radiofrequency transseptal needles. Of those, 232 propensity score-matched patients (116 with each needle type) were included in the analysis. All patients had cerebral MRI performed 1 or 2 days after the procedure. Baseline characteristics were similar between the two groups. Total procedure time was significantly shorter in Group RF than Group non-RF (167 ± 50 vs. 181 ± 52 min, P = 0.01). ACE was detected by MRI in 59 (25%) patients. All patients with ACE were asymptomatic. Incidence of ACE was lower in Group RF than Group non-RF (19 vs. 32%, P = 0.02). B-type natriuretic peptide level was higher in the patients with ACE as compared to those without ACE (65.2 ± 68.7 vs. 44.7 ± 55.1 pg/ml, P = 0.02). In multivariable analysis, the use of RF needle and BNP level was related to the incidence of ACE (OR = 0.499, 95% CI 0.270-0.922, P = 0.03 and OR = 1.005, 95% CI 1.000-1.010, P = 0.03). Use of RF needle for transseptal puncture was associated with lower total procedure time and risk of ACE during catheter ablation of AF.

Atrial fibrillation diagnosed by a medical checkup is associated with a poor outcome of catheter ablation.

Atrial fibrillation (AF), especially asymptomatic cases, is often detected by medical checkups. We investigated the outcome of AF ablation in cases detected by medical checkups. We reviewed the data of 735 patients with AF (56 ± 10 years, paroxysmal: 441 patients) who underwent initial catheter ablation. All patients were divided into two groups based on their AF being diagnosed either by a medical checkup (group M) or not (group NM). AF was diagnosed by medical checkups in 263 (36%) patients. In Group M, the age was younger, time from the diagnosis to ablation shorter, left atrium dimension larger, and left ventricular ejection fraction lower than in Group NM. Male gender, persistent AF, and asymptomatic AF were more frequently seen in Group M than in Group NM. A mean of 13 ± 11 months after the initial ablation procedure, AF recurrence was more frequently observed in group M compared to group NM (P = 0.018). While the AF recurrence rate was similar in both groups in persistent AF patients (P = 0.87), it was more frequently observed in Group M than in Group NM in paroxysmal AF patients (P = 0.005). AF diagnosed by medical checkups was often associated with a worse outcome of catheter ablation, especially in paroxysmal AF patients.

Total absence of pulmonary vein potentials in a patient with paroxysmal atrial fibrillation: was it really isolated?

We herein present a case (72 years, male) with total absence of pulmonary veins (PVs) potentials at the beginning of the first procedure for paroxysmal atrial fibrillation (AF), demonstrating dormant conduction between the left atrium and all PVs revealed by adenosine triphosphate provocation with relation to the incidence of AF. He was free from atrial arrhythmias during 1 year follow-up after complete PV isolation with the elimination of multiple transient dormant conductions by circular mapping catheter guide ablation.

Percutaneous retrieval of a radiolucent anchoring sleeve embolized in pulmonary artery during pacemaker implantation.

An 85-year-old female presented to our institution with symptomatic sick sinus syndrome. During pacemaker implantation, an anchoring sleeve in the right ventricular lead was embolized in the left pulmonary artery. Although the anchoring sleeve was radiolucent, digital subtraction angiography revealed an angiographic filling defect in the lower branch of the left pulmonary artery, and a snare catheter enabled the anchoring sleeve to be grasped and extracted.

Catheter ablation of persistent atrial fibrillation in a patient with cor triatriatum sinister demonstrating a total common trunk of the pulmonary vein.

A 57-year-old male with persistent atrial fibrillation (AF) was referred for catheter ablation. Multidetector computed tomography (MDCT) revealed that a membrane divided the left atrium into two chambers, thus indicating the presence of cor triatriatum sinister. A 3D image reconstructed by MDCT showed that the accessory atrium received the left common and the right side PVs, as if it were a total common trunk, and this then flowed into the main atrium. After isolation of the pulmonary vein and posterior wall from the left atrium, AF could not be induced by any programmed pacing. The patient has remained free from AF during the 1 year of follow-up.

Paradoxical responses to pacing maneuvers differentiating atrioventricular node reentrant tachycardia and junctional tachycardia.

A 40-year-old female presented at our hospital because of heart palpitations. During an electrophysiological study, atrioventricular (AV) conduction showed dual AV nodal physiology. Three types of supraventricular tachycardia (SVT) were induced. The initiation of SVT was reproducibility dependent on a critical A-H interval prolongation. An early premature atrial contraction during SVT repeatedly advanced the immediate His potential with termination of the tachycardia, indicating AV node reentrant tachycardia (AVNRT). However, after atrial overdrive pacing during SVT without termination of the tachycardia, the first return electrogram resulted in an AHHA response, consistent with junctional tachycardia. The mechanism of paradoxical responses to pacing maneuvers differentiating AVNRT and junctional tachycardia was discussed.

Influence of the concomitant use of heparin on the effects of warfarin during catheter ablation for atrial fibrillation.

Warfarin is widely used to perform catheter ablation for atrial fibrillation (AF). Heparin is usually administered during this procedure to prevent thromboembolic events, while protamine is used to reduce the incidence of bleeding complications. The purpose of this study was to investigate the influence of heparin and protamine administration on the effects of warfarin and its safety. The subjects included 226 AF patients (206 males, 54.9 ± 9.1 years, paroxysmal/persistent AF: 118/108) undergoing AF ablation with the discontinuation of warfarin administration over 2 days. Heparin was administered to achieve an activated clotting time (ACT) above 300 s during the procedure. Several parameters of the coagulation status, including the prothrombin time international normalized ratio (PT-INR) and ACT values, measured immediately before and after protamine infusion were compared. The mean value of PT-INR prior to ablation was 1.9 ± 0.6. At the end of the procedure, the mean ACT and PT-INR values were 348.0 ± 52.9 and 2.9 ± 0.7, respectively. Following the infusion of 30 mg of protamine, both the ACT and PT-INR values significantly decreased, to 159.6 ± 31.0 (p < 0.0001) and 1.6 ± 0.3 (p < 0.0001), respectively. No cases of symptomatic cerebral infarction were observed, although femoral hematomas developed in 17 (7.5 %) of the patients without further consequence. The concomitant use of heparin augments the effect of warfarin. Meanwhile, protamine administration immediately reverses both the ACT and PT-INR, indicating the applicability of protamine for AF ablation in patients under the mixed administration of heparin and warfarin.

Filling defects of the left atrial appendage on multidetector computed tomography: their disappearance following catheter ablation of atrial fibrillation and the detection of LAA thrombi by MDCT.

Filling defects of the left atrial appendage (LAA) on multidetector computed tomography (MDCT) are known to occur, not only due to LAA thrombi formation, but also due to the disturbance of blood flow in the LAA of patients with atrial fibrillation (AF). The purpose of this study was to evaluate the impact of the maintenance of sinus rhythm via ablation on the incidence of LAA filling defects on MDCT in patients with AF. A total of 459 consecutive patients were included in the present study. Prior to ablation, MDCT and transesophageal echocardiography (TEE) were performed. AF ablation was performed in patients without LAA thrombi confirmed on TEE. The LAA filling defects were evaluated on MDCT at 3 months after ablation. LAA filling defects were detected on MDCT in 51 patients (11.1 %), among whom the absence of LAA thrombi was confirmed in 42 patients using TEE. The LAA Doppler velocity in patients with LAA filling defects was lower than that of patients without filling defects (0.61 ± 0.19 vs. 0.47 ± 0.21 m/s; P < 0.0001). The sensitivity, specificity and negative predictive value of MDCT in the detection of thrombi were 100, 91 and 100 %, respectively. No LAA filling defects were observed on MDCT at 3 months after ablation in any of the patients, including the patients in whom filling defects were noted prior to the procedure. MDCT is useful for evaluating the presence of LAA thrombi and the blood flow of the LAA. The catheter ablation of AF not only suppresses AF, but also eliminates LAA filling defect on MDCT suggesting the improvement of LAA blood flow.

The role of successful catheter ablation in patients with paroxysmal atrial fibrillation and prolonged sinus pauses: outcome during a 5-year follow-up.

AIMS: Although patients with paroxysmal atrial fibrillation (AF) and prolonged sinus pauses [tachycardia-bradycardia syndrome (TBS)] are generally treated by permanent pacemaker, catheter ablation has been reported to be a curative therapy for TBS without pacemaker implantation. The purpose of this study was to define the potential role of successful ablation in patients with TBS. METHODS AND RESULTS: Of 280 paroxysmal AF patients undergoing ablation, 37 TBS patients with both AF and symptomatic sinus pauses (age: 62 ± 8 years; mean maximum pauses: 6 ± 2 s) were analysed. During the 5.8 ± 1.2 years (range: 5-8.7 years) follow-up, both tachyarrhythmia and bradycardia were eliminated by a single procedure in 19 of 37 (51%) patients. Repeat procedures were performed in 14 of 18 patients with tachyarrhythmia recurrence (second: 12 and third: 2 patients). During the repeat procedure, 79% (45 of 57) of previously isolated pulmonary veins (PVs) were reconnected to the left atrium. Pulmonary vein tachycardia initiating the AF was found in 46% (17 of 37) and 43% (6 of 14) of patients during the initial and second procedure, respectively. Finally, 32 (86%) patients remained free from AF after the last procedure. Three patients (8%) required pacemaker implantation, one for the gradual progression of sinus dysfunction during a period of 6.5 years and the others for recurrence of TBS 3.5 and 5.5 years after ablation, respectively. CONCLUSION: Catheter ablation can eliminate both AF and prolonged sinus pauses in the majority of TBS patients. Nevertheless, such patients should be continuously followed-up, because gradual progression of sinus node dysfunction can occur after a long period of time.

Improvement of atrioventricular conduction following catheter ablation of atrioventricular nodal reentry tachycardia in a patient with a prolonged PR interval.

We herein present the case of a 60-year-old male with narrow QRS tachycardia who had a remarkable PR prolongation during sinus rhythm. The tachycardia was diagnosed as a slow-fast atrioventricular nodal reentry tachycardia. Slow pathway ablation was performed after the confirmation of the presence of an antegrade fast pathway. Following the elimination of the slow pathway, the PR and atrio-His intervals became shortened from 470 and 420 to 170 and 120 ms, respectively. Moreover, the improvement of atrioventricular conduction after the slow pathway ablation lasted for at least 34 months.

Right-to-left shunt via iatrogenic atrial septal defect requiring emergency surgical repair following cryoballoon atrial fibrillation ablation in a patient with arrhythmogenic right ventricular cardiomyopathy.

An 81-year-old woman with arrhythmogenic right ventricular cardiomyopathy underwent catheter ablation for atrial fibrillation and atrial flutter. Hypoxemia refractory to the administration of oxygen was seen after transseptal puncture. Transthoracic echocardiography revealed right to left shunt via an iatrogenic atrial septal defect (IASD) that was increased by tricuspid regurgitation flow. Her hypoxemia improved after IASD occlusion with the inflation of a venogram balloon catheter. Emergent surgical IASD closure was successfully performed. IASD after transseptal puncture for atrial fibrillation ablation infrequently causes severe complications that require emergent repair. Learning objective: Some cases requiring iatrogenic atrial septal defect (IASD) closure after atrial fibrillation (AF) ablation have been reported. We describe the case of an arrhythmogenic right ventricular cardiomyopathy patient with right to left shunt via an IASD which required emergent surgical repair after AF ablation. Right to left shunt after trans-septal puncture is rare, however it can be an emergent life-threatening complication. IASD occlusion with venogram balloon catheter is helpful for the diagnosis and the short-term solution.

Registry for Evaluating Healthy Life Expectancy and Long-Term Outcomes after Catheter Ablation of Atrial Fibrillation in the Very Elderly (REHEALTH AF) study: rationale and design of a prospective, multicentre, observational, comparative study.

INTRODUCTION: Data are lacking on the extent to which patients with non-valvular atrial fibrillation (AF) who are aged ≥80 years benefit from ablation treatment. The question pertains especially to patients' postablation quality of life (QoL) and long-term clinical outcomes. METHODS AND ANALYSIS: We are initiating a prospective, registry-based, multicentre observational study that will include patients aged ≥80 years with non-valvular AF who choose to undergo treatment by catheter ablation and, for comparison, such patients who do not choose to undergo ablation (either according to their physician's advice or their own preference). Study subjects are to be enrolled from 52 participant hospitals and three clinics located throughout Japan from 1 June 2022 to 31 December 2023, and each will be followed up for 1 year. The planned sample size is 660, comprising 220 ablation group patients and 440 non-ablation group patients. The primary endpoint will be the composite incidence of stroke/transient ischaemic attack (TIA) or systemic embolism (SE), another cardiovascular event, major bleeding and/or death from any cause. Other clinical events such as postablation AF recurrence, a fall or bone fracture will be recorded. We will collect standard clinical background information plus each patient's Clinical Frailty Scale score, AF-related symptoms, QoL (Five-Level Version of EQ-5D) scores, Mini-Mental State Examination (optional) score and laboratory test results, including measures of nutritional status, on entry into the study and 1 year later, and serial changes in symptoms and QoL will also be secondary endpoints. Propensity score matching will be performed to account for covariates that could affect study results. ETHICS AND DISSEMINATION: The study conforms to the Declaration of Helsinki and the Ethical Guidelines for Clinical Studies issued by the Ministry of Health, Labour and Welfare, Japan. Results of the study will be published in one or more peer-reviewed journals. TRIAL REGISTRATION NUMBER: UMIN000047023.