The purpose of this clinical study is to test the hypothesis that market released Cardiac Resynchronization Therapy (CRT) devices which contain the AdaptivCRT® (aCRT) algorithm have a superior outcome compared to standard CRT devices in CRT indicated patients with normal atrio-ventricular (AV) conduction and left bundle branch block (LBBB).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3,797
Combined Endpoint of All-cause Mortality and Intervention for Heart Failure Decompensation
The first occurrence of death or intervention for heart failure decompensation (defined as an event requiring invasive intervention or inpatient hospitalization).
Time frame: from subject randomization until the first occurrence of death or intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
All-cause Mortality
All-cause mortality in the aCRT ON group vs the aCRT OFF group
Time frame: from subject randomization until the occurrence of death, median follow-up 4.9 years (max. follow-up 8.1 years)
Percent of Patients With Interventions for Heart Failure Decompensation
First occurence of intervention for heart failure decompensation is defined as an event requiring invasive intervention or inpatient hospitalization.
Time frame: from subject randomization until the first occurrence of intervention for heart failure decompensation, median follow-up 4.9 years (max. follow-up 8.1 years)
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 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.
Time frame: CCS at 6 month post randomization
Atrial Fibrillation
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CardioVascular Associates of Mesa
Mesa, Arizona, United States
Phoenix Cardiovascular Research Group, LLC
Phoenix, Arizona, United States
Saint Vincent Heart Clinic Arkansas
Little Rock, Arkansas, United States
Scripps Green Hospital Scripps Clinic Torrey Pines
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Coggins & Levy Medical Associates
San Jose, California, United States
Stanford Hospital & Clinics
Stanford, California, United States
Saint Joseph's Medical Center
Stockton, California, United States
Penrose Hospital
Colorado Springs, Colorado, United States
Medical Center of the Rockies
Loveland, Colorado, United States
...and 210 more locations
Occurrence of atrial fibrillation lasting \>6 hours in one day
Time frame: from subject randomization until the first occurrence of atrial fibrillation lasting >6 hours in one day, median follow-up 4.9 years (max. follow-up 8.1 years)
Change in Quality of Life Measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ)
The overall summary score of the Kansas City Cardiomyopathy Questionnaire will be analyzed. The KCCQ measures Quality of Life on a 0-100 scale with higher scores indicating better QoL
Time frame: from baseline to 24M follow up
Change in Quality of Life Measured by the EQ-5D
The EQ-5D descriptive system comprises the following five dimensions, each describing a different aspect of health: MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION. Each dimension has three levels: no problems, some problems, extreme problems (labelled 1-3). We calculated the EQ-5D summary index by applying a specific formula providing a valuation to the health states (Shaw et al. Medical Care 2005). For the summary index, value 0 represents health that is valued as equal to death and value 1 represents best possible health.
Time frame: from baseline to 24M follow up
All-cause Re-admissions Within 30 Days After a Heart Failure Admission Per 100 Patient Years
All-cause hospital re-admissions within 30 days after discharge from a heart failure admission are reported as number of cases per 100 patient years
Time frame: from subject randomization until study exit, median follow-up 4.9 years (max. follow-up 8.1 years)