Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization

Abbott Medical Devices1 site in 1 country1,833 target enrollmentMay 2003

ConditionsAtrioventricular Block Ventricular Dysfunction

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Atrioventricular Block
Sponsor: Abbott Medical Devices
Enrollment: 1833
Locations: 1
Primary Endpoint: Death or Heart Failure Hospitalization
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

May 2003

End Date

October 2014

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Presence of an indication for ventricular pacing according to the actual guidelines for the implantation of cardiac pacemakers and a need for frequent (or even permanent) ventricular pacing for:
•Permanent 3rd degree atrioventricular (AV)-block or
•Intermittent 3rd degree AV-block in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
•2nd degree AV-block type Mobitz II in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
•2nd degree AV-block type Mobitz I (if indicated) in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
•1st degree AV-block with a pQ-interval ≥ 220 ms and indication for ventricular pacing (includes indication for ventricular pacing based on long HV interval measured during invasive electrophysiological testing) or
•Sick-sinus-syndrome with symptomatic sinus bradycardia or sinus arrest as primary indication for device implantation in combination with long 1st degree AV-block with a pQ-interval ≥ 220 ms or
•Chronic (permanent) atrial fibrillation (flutter or tachycardia) with a spontaneous heart (ventricular) rate at rest ≤ 60/min or
•Chronic (permanent) atrial fibrillation (flutter or tachycardia) with a spontaneous heart (ventricular) rate at rest ≤ 75/min, if initiation or increase of pharmacological treatment with a relevant heart rate lowering effect (negative chronotropic effect) is planned for the time after pacemaker implantation (i.e. ß-blockers for heart failure and rate control)
•Patients scheduled for AV node ablation

Exclusion Criteria

•Implanted Cardioverter Defibrillator or consideration for implantation of an ICD due to arrhythmia indication. However, ICD implant for primary prevention of sudden cardiac death in patients with LVEF ≤ 35 % (in accordance with the actual guidelines for the implantation of arrhythmia devices\[LVEF \< 30%\] and in accordance with the results of the SCD-Heft study \[LVEF \< 35%) will be allowed.
•Implanted ventricular pacing device
•Status 1 for cardiac transplantation and likelihood to receive transplantation within 2 years (these patients would not be expected to fulfill the follow-up requirements as outlined in this protocol)
•Evidence of acute left ventricular dysfunction and high probability for its reversibility (e.g. acute myocarditis, tachycardiomyopathy)
•Implanted prosthetic tricuspid valve
•Severe musculoskeletal disorder(s)
•Age below 18 years
•Current or planned pregnancy in the next 6 months
•Current or recent (within the past 30 days) participation in any other clinical investigation
•Life expectancy of less than 6 months

Outcomes

Primary Outcomes

Death or Heart Failure Hospitalization

Time Frame: Study duration (5.7 years mean follow-up)

Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization

Total Mortality

Time Frame: Study duration (5.7 years mean follow-up)

Number of deaths observed

Secondary Outcomes

Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©(24 months post-implant)
Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits)(Study duration (5.7 years mean follow-up))
Incidence of Hospitalizations for Deterioration of Heart Failure(Study duration (5.7 years mean follow-up))
Duration of Hospitalizations for Cardiovascular Events(Study Duration (5.7 years mean follow-up))
Adverse Events Related to Left Ventricular Lead(Study Duration (5.7 years mean follow-up))
Cardiac Structure and Function(12 & 24 months)
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test(24 months post-implant)
Incidence of Hospitalizations for Any Reason(Study duration (5.7 years mean follow-up))
Successful Implantation of the Left Ventricular Lead(Implantation)
Duration of Hospitalizations for Deterioration of Heart Failure(Study Duration (5.7 years mean follow-up))
Death Due to Cardiovascular Causes(Study duration (5.7 years mean follow-up))
Incidence of Hospitalizations for Cardiovascular Events(Study duration (5.7 years mean follow-up))
Duration of Hospitalizations for Any Reason(Study duration (5.7 years mean follow-up))