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Heart Rhythm. 2017 May;14(5):763-782. doi: 10.1016/j.hrthm.2017.01.032. Epub 2017 Feb 2.

The burden of proof: The current state of atrial fibrillation prevention and treatment trials.

Author information

1
Royal Brompton & Harefield NHS Trust, London, United Kingdom. Electronic address: rosita.zakeri@doctors.org.uk.
2
Cleveland Clinic, Cleveland, Ohio.
3
Johns Hopkins Hospital, Baltimore, Maryland.
4
Royal Brompton & Harefield NHS Trust, London, United Kingdom.
5
Arizona State University, Phoenix, Arizona.
6
Massachusetts General Hospital, Boston, Massachusetts.
7
Boston Scientific, St Paul, Minnesota.
8
Lankenau Heart Institute and Jefferson Medical College, Wynnewood, Pennsylvania.
9
Duke Clinical Research Institute, Durham, North Carolina.
10
University of Michigan, Ann Arbor, Michigan.
11
INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT, France.
12
Karolinska Institute, Stockholm, Sweden.

Abstract

Atrial fibrillation (AF) is an age-related arrhythmia of enormous socioeconomic significance. In recent years, our understanding of the basic mechanisms that initiate and perpetuate AF has evolved rapidly, catheter ablation of AF has progressed from concept to reality, and recent studies suggest lifestyle modification may help prevent AF recurrence. Emerging developments in genetics, imaging, and informatics also present new opportunities for personalized care. However, considerable challenges remain. These include a paucity of studies examining AF prevention, modest efficacy of existing antiarrhythmic therapies, diverse ablation technologies and practice, and limited evidence to guide management of high-risk patients with multiple comorbidities. Studies examining the long-term effects of AF catheter ablation on morbidity and mortality outcomes are not yet completed. In many ways, further progress in the field is heavily contingent on the feasibility, capacity, and efficiency of clinical trials to incorporate the rapidly evolving knowledge base and to provide substantive evidence for novel AF therapeutic strategies. This review outlines the current state of AF prevention and treatment trials, including the foreseeable challenges, as discussed by a unique forum of clinical trialists, scientists, and regulatory representatives in a session endorsed by the Heart Rhythm Society at the 12th Global CardioVascular Clinical Trialists Forum in Washington, DC, December 3-5, 2015.

KEYWORDS:

Ablation; Atrial fibrillation; Personalized medicine; Prevention; Randomized controlled trial

PMID:
28161513
PMCID:
PMC5403606
DOI:
10.1016/j.hrthm.2017.01.032
[Indexed for MEDLINE]
Free PMC Article

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