Clinical Trial Principles and Endpoint Definitions for Paravalvular Leaks in Surgical Prosthesis.
Eur Heart J
; 39(15): 1224-1245, 2018 04 14.
Article
in En
| MEDLINE
| ID: mdl-28430909
ABSTRACT
The VARC (Valve Academic Research Consortium) for transcatheter aortic valve replacement set the standard for selecting appropriate clinical endpoints reflecting safety and effectiveness of transcatheter devices, and defining single and composite clinical endpoints for clinical trials. No such standardization exists for circumferentially sutured surgical valve paravalvular leak (PVL) closure. This document seeks to provide core principles, appropriate clinical endpoints, and endpoint definitions to be used in clinical trials of PVL closure devices. The PVL Academic Research Consortium met to review evidence and make recommendations for assessment of disease severity, data collection, and updated endpoint definitions. A 5-class grading scheme to evaluate PVL was developed in concordance with VARC recommendations. Unresolved issues in the field are outlined. The current PVL Academic Research Consortium provides recommendations for assessment of disease severity, data collection, and endpoint definitions. Future research in the field is warranted.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Aortic Valve
/
Heart Valve Prosthesis
/
Clinical Trials as Topic
/
Transcatheter Aortic Valve Replacement
/
Vascular Closure Devices
Type of study:
Clinical_trials
/
Etiology_studies
/
Guideline
/
Risk_factors_studies
Limits:
Humans
Language:
En
Journal:
Eur Heart J
Year:
2018
Type:
Article