Status:
COMPLETED
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
Lead Sponsor:
Abbott Medical Devices
Conditions:
Atrioventricular Block
Ventricular Dysfunction
Eligibility:
All Genders
18+ years
Phase:
NA
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 prof...
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 biventric...
Eligibility Criteria
Inclusion
- 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
- Any QRS duration and morphology
- Left ventricular ejection fraction (LVEF) without limit as measured by echocardiography (in at least one plane, either 4- or 2-chamber or apical long axis view)
- Signed written informed consent of the patient or a first-degree relative for study participation after informing the patient/relative about the risks and the aim of the study
- Willingness and ability to comply with the prescribed follow-up tests and schedule of evaluations.
- Absence of an implanted ventricular pacing device (patients with atrial pacemakers and new need for ventricular pacing may be included)
Exclusion
- 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
- Patient's inability to independently comprehend and complete the Quality of Life (QoL) questionnaire
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
1833 Patients enrolled
Trial Details
Trial ID
NCT00187278
Start Date
May 1 2003
End Date
October 1 2014
Last Update
January 25 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35033