TY - JOUR
T1 - The burden of proof
T2 - The current state of atrial fibrillation prevention and treatment trials
AU - Zakeri, Rosita
AU - Van Wagoner, David R.
AU - Calkins, Hugh
AU - Wong, Tom
AU - Ross, Heather M.
AU - Heist, E. Kevin
AU - Meyer, Timothy E.
AU - Kowey, Peter R.
AU - Mentz, Robert J.
AU - Cleland, John G.
AU - Pitt, Bertram
AU - Zannad, Faiez
AU - Linde, Cecilia
N1 - Publisher Copyright:
© 2017 Heart Rhythm Society
PY - 2017/5
Y1 - 2017/5
N2 - 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.
AB - 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.
KW - Ablation
KW - Atrial fibrillation
KW - Personalized medicine
KW - Prevention
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85016044650&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85016044650&partnerID=8YFLogxK
U2 - 10.1016/j.hrthm.2017.01.032
DO - 10.1016/j.hrthm.2017.01.032
M3 - Article
C2 - 28161513
AN - SCOPUS:85016044650
SN - 1547-5271
VL - 14
SP - 763
EP - 782
JO - Heart Rhythm
JF - Heart Rhythm
IS - 5
ER -