The Mid-Q Response study is a prospective, multi-center, randomized controlled, interventional, single-blinded, post-market study. The purpose of the Mid-Q Response study is to test the hypothesis that the AdaptivCRT (aCRT) algorithm is superior to standard CRT therapy regarding patient outcomes in CRT indicated patients with moderate QRS duration, preserved atrioventricular (AV) conduction and left bundle branch block (LBBB). The study will be executed at approximately 60 centers in Asia. The subjects will be randomly assigned in a 1:1 ratio to the aCRT ON (Adaptive Bi-V and LV) group or the aCRT OFF (Nonadaptive CRT) group. The primary objective is to test the hypothesis that aCRT ON increases the proportion of patients that improve on the Clinical Composite Score (CCS) compared to aCRT OFF at 6 months of follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
177
Gleneagles Jerudong Park Medical Centre
Bandar Seri Begawan, Brunei
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
Grantham Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
National Cardiovascular Center Harapan Kita
Clinical Composite Score
The Clinical Composite Score (CCS) classifies patients according their clinical status at 6 months post-randomization into categories Improved, Unchanged, and Worsened. A patient is classified Worsened in case of death, hospitalization for worsening heart failure, worsened New York Heart Association (NYHA) class (using last observation carried forward), or worsened status on the Global Assessment Score. Also, patients that exit the study or cross over because of worsening heart failure are classified Worsened. A patient is classified Improved when not Worsened and there is an improvement in NYHA class or Global Assessment Score. Patients that are not Worsened or Improved are Unchanged including all patients that miss NYHA class and Global Assessment Score data and are not classified Worsened because of death, HF hospitalization, exit or crossover.
Time frame: 6 months post-randomization
Change in New York Heart Association (NYHA) Class
NYHA class is an ordinal variable with higher classes indicating a worse degree of heart failure: Class I - No symptoms and no limitation in ordinary physical activity, e.g. shortness of breath when walking, climbing stairs etc. Class II - Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g. walking short distances (20-100 m).Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest. Mostly bedbound patients.
Time frame: Baseline to 6 and 12 months post-randomization
Occurrence of Hospitalizations for Worsening Heart Failure
Defined as an event requiring inpatient hospitalization or invasive intervention
Time frame: 12 months post-randomization
All-cause Mortality
All-cause mortality in the aCRT ON group vs the aCRT OFF group
Time frame: 12 months post-randomization
Cardiovascular-related Mortality
Defined as all cardiac deaths as well as any cardiovascular deaths that are not directly a result of mechanical or electrical heart dysfunction.
Time frame: 12 months post-randomization
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Jakarta, Indonesia
University of Fukui Hospital
Fukui, Japan
Kokura Memorial Hospital
Fukuoka, Japan
Hirosaki University Hospital
Hirosaki, Japan
Hiroshima Prefectural Hospital
Hiroshima, Japan
...and 51 more locations