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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: St. Jude Medical

Current Primary Outcome:

  • Patient survival time after hardware-randomization: total mortality [ Time Frame: Event driven ]
  • Combined endpoint of overall survival time to first hospitalization where heart failure is a primary cause of hospitalization from the hardware-randomization [ Time Frame: Event driven ]


Original Primary Outcome:

Current Secondary Outcome:

  • Death due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) [ Time Frame: Event driven ]
  • Functional capacity as measured by the distance covered in the 6-minute walk test [ Time Frame: 1 and 2 years ]
  • Health related Quality of Life measured by the Minnesota Living With Heart Failure questionnaire© [ Time Frame: 1 and 2 years ]
  • Rate and duration of hospitalizations for deterioration of heart failure [ Time Frame: Event driven ]
  • Rate and duration of hospitalizations for cardiovascular events [ Time Frame: Event driven ]
  • Rate and duration of hospitalizations for any reason [ Time Frame: Event driven ]
  • Cardiac structure and function (echocardiographic analysis according to the echo core laboratory results): [ Time Frame: 12 & 24 months ]
  • Implantation procedure [ Time Frame: Implantation ]
    AEs
  • left ventricular lead [ Time Frame: study duration ]
    AEs
  • all leads [ Time Frame: study duration ]
    AEs
  • Successful implantation of the left ventricular lead (St. Jude Medical) [ Time Frame: Implantation ]
    Performance of lead
  • Chronic atrial fibrillation (defined as presence of atrial fibrillation in two subsequent ECG´s/visits) [ Time Frame: Study duration ]


Original Secondary Outcome:

Information By: St. Jude Medical

Dates:
Date Received: September 13, 2005
Date Started: May 2003
Date Completion:
Last Updated: August 6, 2015
Last Verified: August 2015