The primary purpose of the study is to evaluate if patients with a standard indication for permanent ventricular pacing, left ventricular ejection fraction without limit, or any QRS duration will profit from the prevention of ventricular desynchronisation.
The study will be performed as a controlled, single-blind, international, multicenter, prospective, randomized, parallel group design. In order to pragmatically examine the effectiveness of biventricular pacing in patients with an indication for ventricular pacing, the study group with biventricular pacing is compared to a control group with standard pacemakers which only allow univentricular (right ventricular) stimulation, as it has been the standard outside of clinical studies until so far.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,833
Biventricular Pacemaker implant
Standard Pacemaker implant
Klinikum der Philipps-Universität Marburg
Marburg, Germany
Total Mortality
Number of deaths observed
Time frame: Study duration (5.7 years mean follow-up)
Death or Heart Failure Hospitalization
Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization
Time frame: Study duration (5.7 years mean follow-up)
Death Due to Cardiovascular Causes
Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)
Time frame: Study duration (5.7 years mean follow-up)
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Time frame: 12 months post-implant
Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Time frame: 12 months post-implant
Incidence of Hospitalizations for Deterioration of Heart Failure
Time frame: Study duration (5.7 years mean follow-up)
Incidence of Hospitalizations for Cardiovascular Events
Time frame: Study duration (5.7 years mean follow-up)
Incidence of Hospitalizations for Any Reason
Time frame: Study duration (5.7 years mean follow-up)
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Cardiac Structure and Function
Time frame: 12 & 24 months
Successful Implantation of the Left Ventricular Lead
Time frame: Implantation
Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits)
Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits.
Time frame: Study duration (5.7 years mean follow-up)
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Time frame: 24 months post-implant
Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Time frame: 24 months post-implant
Duration of Hospitalizations for Deterioration of Heart Failure
Time frame: Study Duration (5.7 years mean follow-up)
Duration of Hospitalizations for Cardiovascular Events
Time frame: Study Duration (5.7 years mean follow-up)
Duration of Hospitalizations for Any Reason
Time frame: Study duration (5.7 years mean follow-up)
Adverse Events Related to Left Ventricular Lead
Only serious adverse events related to the left ventricular lead are included.
Time frame: Study Duration (5.7 years mean follow-up)