Journal of arrhythmia · 2022
Design of Mid-Q Response: A prospective, randomized trial of adaptive cardiac resynchronization therapy in Asian patients.
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Kusano Kengo, Park Seung-Jung, Johar Sofian, Lim Toon Wei, Gerritse Bart, Hidaka Kazuhiro, Aonuma Kazutaka
Аннотация
AIMS: The aim of the Mid-Q Response study is to test the hypothesis that adaptive preferential left ventricular-only pacing with the AdaptivCRT algorithm has superior clinical outcomes compared to conventional cardiac resynchronization therapy (CRT) in heart failure (HF) patients with moderately wide QRS duration (≥120 ms and <150 ms), left bundle branch block (LBBB), and normal atrioventricular (AV) conduction (PR interval ≤200 ms).
METHODS: This prospective, multi-center, randomized, controlled, clinical study is being conducted at approximately 60 centers in Asia. Following enrollment and baseline assessment, eligible patients are implanted with a CRT system equipped with the AdaptivCRT algorithm and are randomly assigned in a 1:1 ratio to have AdaptivCRT ON (Adaptive Bi-V and LV pacing) or AdaptivCRT OFF (Nonadaptive CRT). A minimum of 220 randomized patients are required for analysis of the primary endpoint, clinical composite score (CCS) at 6 months post-implant. The secondary and ancillary endpoints are all-cause and cardiovascular death, hospitalizations for worsening HF, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), atrial fibrillation (AF), and cardiovascular adverse events at 6 or 12 months.
CONCLUSION: The Mid-Q Response study is expected to provide additional evidence on the incremental benefit of the AdaptivCRT algorithm among Asian HF patients with normal AV conduction, moderately wide QRS, and LBBB undergoing CRT implant.
METHODS: This prospective, multi-center, randomized, controlled, clinical study is being conducted at approximately 60 centers in Asia. Following enrollment and baseline assessment, eligible patients are implanted with a CRT system equipped with the AdaptivCRT algorithm and are randomly assigned in a 1:1 ratio to have AdaptivCRT ON (Adaptive Bi-V and LV pacing) or AdaptivCRT OFF (Nonadaptive CRT). A minimum of 220 randomized patients are required for analysis of the primary endpoint, clinical composite score (CCS) at 6 months post-implant. The secondary and ancillary endpoints are all-cause and cardiovascular death, hospitalizations for worsening HF, New York Heart Association (NYHA) class, Kansas City Cardiomyopathy Questionnaire (KCCQ), atrial fibrillation (AF), and cardiovascular adverse events at 6 or 12 months.
CONCLUSION: The Mid-Q Response study is expected to provide additional evidence on the incremental benefit of the AdaptivCRT algorithm among Asian HF patients with normal AV conduction, moderately wide QRS, and LBBB undergoing CRT implant.