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First granted example of novel FDA trial design under Expedited Access Pathway for premarket approval: BeAT-HF.
Zile, Michael R; Abraham, William T; Lindenfeld, JoAnn; Weaver, Fred A; Zannad, Faiez; Graves, Todd; Rogers, Tyson; Galle, Elizabeth G.
Affiliation
  • Zile MR; Medical University of South Carolina, Charleston, South Carolina and the Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: zilem@musc.edu.
  • Abraham WT; Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA.
  • Lindenfeld J; Vanderbilt Heart and Vascular Institute, Nashville, TN, USA.
  • Weaver FA; Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.
  • Zannad F; Inserm Centre d'Investigation, CHU de Nancy, Institute Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France.
  • Graves T; Berry Consultants, Austin, TX, USA.
  • Rogers T; NAMSA, Inc., Minneapolis, MN, USA.
  • Galle EG; CVRx, Inc., Minneapolis, MN, USA.
Am Heart J ; 204: 139-150, 2018 10.
Article in En | MEDLINE | ID: mdl-30118942
Subject(s)
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Full text: 1 Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Electric Stimulation Therapy / Drug Approval / Baroreflex / Heart Failure Type of study: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Am Heart J Year: 2018 Type: Article
Fulltext
Add to My VHL
Print
XML
PubMed Links
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Full text: 1 Database: MEDLINE Main subject: Randomized Controlled Trials as Topic / Electric Stimulation Therapy / Drug Approval / Baroreflex / Heart Failure Type of study: Clinical_trials / Guideline / Observational_studies / Prognostic_studies / Qualitative_research / Risk_factors_studies Limits: Humans Country/Region as subject: America do norte Language: En Journal: Am Heart J Year: 2018 Type: Article