Considerations for Using Atrial Fibrillation Burden as a Surrogate Endpoint A Report from the Cardiovascular Sciences Research Consortium.

Krishna Pundi¹, Charu Gandotra², William Sanders², Fortunato Senatore², Jason G Andrade³, C Michael Gibson⁴, Paulus Kirchhof⁵, Steven A Lubitz⁶, Jonathan Piccini⁷, Andrea Russo⁸, Kenneth Stein⁹, Mintu P Turakhia¹⁰, Jonathan Seltzer¹¹

¹Veterans Affairs Palo Alto Health Care System, Palo Alto, CA; Department of Medicine, Stanford University School of Medicine, Stanford, CA. Electronic address: kpundi@stanford.edu.

²Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Springs, MD.

³Department of Medicine, Vancouver General Hospital, Vancouver, Canada; Department of Medicine, Montreal Heart Institute, Montreal, Canada.

⁴Baim Institute of Clinical Research, Harvard Medical School, Boston, MA.

⁵Department of Cardiology, University Heart and Vascular Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Cardiovascular Research (DZHK), partner site North, Hamburg, Germany.

⁶Novartis Biomedical Research, Cambridge, MA.

⁷Duke Clinical Research Institute, Duke University, Durham, NC.

⁸Cooper Medical School of Rowan University, Camden, NJ.

⁹Boston Scientific Corporation, Marlborough, MA.

¹⁰Department of Medicine, Stanford University School of Medicine, Stanford, CA; iRhythm Technologies Inc, San Francisco, CA.

¹¹Cardiovascular Sciences Research Consortium, Narberth, PA.

PubMed DOI

Abstract

Atrial fibrillation (AF) care has shifted dramatically, with a focus on early rhythm control to reduce AF-related morbidity and mortality and improve quality of life. However, clinical trials for AF rely on historical definitions of treatment failure, including freedom from recurrence of ≥ 30 seconds of atrial fibrillation/flutter/tachycardia, which is a poor predictor of AF severity, or tradition…

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Create Free Account Sign In

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.