Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing

Gerasimos Filippatos (1) , David Birnie (2) , Michael R. Gold (3) , Bart Gerritse (4) , Ahmad Hersi (5) , Sandra Jacobs (4) , Kengo Kusano , Christophe Leclercq (6, 7, 8) , Wilfried Mullens , Bruce L. Wilkoff

1 NKUA - National and Kapodistrian University of Athens
2 University of Ottawa [Ottawa]
3 MUSC - Medical University of South Carolina [Charleston]
4 Medtronic Bakken Research Center BV
5 KSU - King Saud University [Riyadh]
6 LTSI - Laboratoire Traitement du Signal et de l'Image
7 Service de cardiologie et maladies vasculaires [Rennes] = Cardiac, Thoracic, and Vascular Surgery [Rennes]
8 CIC-IT Rennes

The AdaptResponse trial is designed to test the hypothesis that preferential adaptive left ventricular-only pacing with the AdaptivCRT((R)) algorithm reduces the incidence of the combined endpoint of all-cause mortality and intervention for heart failure (HF) decompensation, compared with conventional cardiac resynchronization therapy (CRT), among patients with a CRT indication, left bundle branch block (LBBB) and normal atrioventricular (AV) conduction. The AdaptResponse study is a prospective, randomized, controlled, single-blinded, multicentre, clinical trial ( Identifier: NCT02205359), conducted at up to 200 centres worldwide. Following enrolment and baseline assessment, eligible subjects will be implanted with a CRT system containing the AdaptivCRT algorithm, and randomized in a 1:1 fashion to either a treatment (AdaptivCRT') or control (Conventional CRT') group. The study is designed to observe a primary endpoint in 1100 patients (event-driven') and approximately 3000 patients will be randomized. The primary endpoint is the composite of all-cause mortality and intervention for HF decompensation; secondary endpoints include all-cause mortality, intervention for HF decompensation, clinical composite score (CCS) at 6 months, atrial fibrillation, quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ), health outcome measured by the EQ-5D instrument, all-cause readmission after a HF admission, and cost-effectiveness. The AdaptResponse clinical trial is powered to assess clinical endpoints and is expected to provide definitive evidence on the incremental utility of AdaptivCRT-enhanced CRT systems.

Mots clés: cardiac resynchronization therapy; left ventricular pacing; optimization; atrioventricular conduction; left bundle branch block; clinical outcome; heart failure

Domaines: Cardiologie et système cardiovasculaire; Santé publique et épidémiologie

Gerasimos Filippatos, David Birnie, Michael R. Gold, Bart Gerritse, Ahmad Hersi, et al.. Rationale and design of the AdaptResponse trial: a prospective randomized study of cardiac resynchronization therapy with preferential adaptive left ventricular-only pacing. European Journal of Heart Failure, 2017, 19 (7), pp.950--957. ⟨10.1002/ejhf.895⟩. ⟨hal-01577962⟩