The burden of proof: The current state of atrial fibrillation prevention and treatment trials.
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.
Royal Brompton & Harefield NHS Trust, London, United Kingdom. Electronic address: rosita.zakeri@doctors.org.uk.
Rosita
R
Zakeri
Cleveland Clinic, Cleveland, Ohio.
David R
DR
Van Wagoner
Johns Hopkins Hospital, Baltimore, Maryland.
Hugh
H
Calkins
Royal Brompton & Harefield NHS Trust, London, United Kingdom.
Tom
T
Wong
Arizona State University, Phoenix, Arizona.
Heather M
HM
Ross
Massachusetts General Hospital, Boston, Massachusetts.
E Kevin
EK
Heist
Boston Scientific, St Paul, Minnesota.
Timothy E
TE
Meyer
Lankenau Heart Institute and Jefferson Medical College, Wynnewood, Pennsylvania.
Peter R
PR
Kowey
Duke Clinical Research Institute, Durham, North Carolina.
Robert J
RJ
Mentz
Royal Brompton & Harefield NHS Trust, London, United Kingdom.
John G
JG
Cleland
University of Michigan, Ann Arbor, Michigan.
Bertram
B
Pitt
INSERM, Centre d'Investigations Cliniques Plurithématique 1433, INSERM U1116, Université de Lorraine, CHRU de Nancy, F-CRIN INI-CRCT, France.
Faiez
F
Zannad
Karolinska Institute, Stockholm, Sweden.
Cecilia
C
Linde
D001281:Atrial Fibrillation / Q000209:etiology / Q000517:prevention & control / Q000628:therapy*; D002986:Clinical Trials as Topic; D006801:Humans
Ablation; Atrial fibrillation; Personalized medicine; Prevention; Randomized controlled trial