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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00187278
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : August 7, 2015
Information provided by (Responsible Party):
Abbott Medical Devices

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.

Condition or disease Intervention/treatment Phase
Atrioventricular Block Ventricular Dysfunction Device: Biventricular Pacing Device: RV Pacing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1833 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization
Study Start Date : May 2003
Actual Primary Completion Date : May 2014
Actual Study Completion Date : October 2014

Arm Intervention/treatment
Active Comparator: RV Pacing
Standard Pacemaker implant
Device: RV Pacing
Standard Pacemaker implant

Experimental: Biventricular Pacing
Biventircular Pacemaker implant
Device: Biventricular Pacing
Biventricular Pacemaker implant

Primary Outcome Measures :
  1. Patient survival time after hardware-randomization: total mortality [ Time Frame: Event driven ]
  2. 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 ]

Secondary Outcome Measures :
  1. Death due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) [ Time Frame: Event driven ]
  2. Functional capacity as measured by the distance covered in the 6-minute walk test [ Time Frame: 1 and 2 years ]
  3. Health related Quality of Life measured by the Minnesota Living With Heart Failure questionnaire© [ Time Frame: 1 and 2 years ]
  4. Rate and duration of hospitalizations for deterioration of heart failure [ Time Frame: Event driven ]
  5. Rate and duration of hospitalizations for cardiovascular events [ Time Frame: Event driven ]
  6. Rate and duration of hospitalizations for any reason [ Time Frame: Event driven ]
  7. Cardiac structure and function (echocardiographic analysis according to the echo core laboratory results): [ Time Frame: 12 & 24 months ]
  8. Implantation procedure [ Time Frame: Implantation ]

  9. left ventricular lead [ Time Frame: study duration ]

  10. all leads [ Time Frame: study duration ]

  11. Successful implantation of the left ventricular lead (St. Jude Medical) [ Time Frame: Implantation ]
    Performance of lead

  12. Chronic atrial fibrillation (defined as presence of atrial fibrillation in two subsequent ECG´s/visits) [ Time Frame: Study duration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • 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 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
  • Patient's inability to independently comprehend and complete the Quality of Life (QoL) questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00187278

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Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35033
Sponsors and Collaborators
Abbott Medical Devices
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Principal Investigator: Reinhard Funck, MD Klinikum der Philipps-Universität Marburg, Germany
Study Chair: Jean-Jacques Blanc, Prof. Hôpital Cavale Blanche, Brest, France
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Responsible Party: Abbott Medical Devices Identifier: NCT00187278    
Other Study ID Numbers: CR03006HF
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 7, 2015
Last Verified: August 2015
Keywords provided by Abbott Medical Devices:
Standard pacing indication
Additional relevant MeSH terms:
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Ventricular Dysfunction
Atrioventricular Block
Heart Diseases
Cardiovascular Diseases
Heart Block
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes