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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00187278
First received: September 13, 2005
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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 Intervention
Atrioventricular Block
Ventricular Dysfunction
Device: Biventricular Pacing
Device: RV Pacing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Patient survival time after hardware-randomization: total mortality [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Death due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC) [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
  • Functional capacity as measured by the distance covered in the 6-minute walk test [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Health related Quality of Life measured by the Minnesota Living With Heart Failure questionnaire© [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
  • Rate and duration of hospitalizations for deterioration of heart failure [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
  • Rate and duration of hospitalizations for cardiovascular events [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
  • Rate and duration of hospitalizations for any reason [ Time Frame: Event driven ] [ Designated as safety issue: Yes ]
  • Cardiac structure and function (echocardiographic analysis according to the echo core laboratory results): [ Time Frame: 12 & 24 months ] [ Designated as safety issue: No ]
  • Implantation procedure [ Time Frame: Implantation ] [ Designated as safety issue: Yes ]
    AEs

  • left ventricular lead [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
    AEs

  • all leads [ Time Frame: study duration ] [ Designated as safety issue: Yes ]
    AEs

  • Successful implantation of the left ventricular lead (St. Jude Medical) [ Time Frame: Implantation ] [ Designated as safety issue: Yes ]
    Performance of lead

  • Chronic atrial fibrillation (defined as presence of atrial fibrillation in two subsequent ECG´s/visits) [ Time Frame: Study duration ] [ Designated as safety issue: No ]

Enrollment: 1833
Study Start Date: May 2003
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187278

Locations
Germany
Klinikum der Philipps-Universität Marburg
Marburg, Germany, 35033
Sponsors and Collaborators
St. Jude Medical
Investigators
Principal Investigator: Reinhard Funck, MD Klinikum der Philipps-Universität Marburg, Germany
Study Chair: Jean-Jacques Blanc, Prof. Hôpital Cavale Blanche, Brest, France
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT00187278     History of Changes
Other Study ID Numbers: CR03006HF
Study First Received: September 13, 2005
Last Updated: July 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Conseil National de l'Ordre des Médecins
Serbia: Medicines and Medical Devices Agency

Keywords provided by St. Jude Medical:
Standard pacing indication

Additional relevant MeSH terms:
Atrioventricular Block
Ventricular Dysfunction
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Block
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014