NCT00187278

Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,833 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atrioventricular Block
• Ventricular Dysfunction

Interventions

Type	Name	Description
DEVICE	Biventricular Pacing	Biventricular Pacemaker implant
DEVICE	RV Pacing	Standard Pacemaker implant

Timeline

• Start date: 2003-05-01
• Primary completion: 2014-05-01
• Completion: 2014-10-01
• First posted: 2005-09-16
• Last updated: 2021-01-25
• Results posted: 2021-01-25

Locations

1 site across 1 country: Germany