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

NCT00187278 | Completed Results DMC

• 1 other identifier: CR03006HF
• Study Type: interventional
• Target: 1,833
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrioventricular Block; Ventricular Dysfunction

Keywords

Standard pacing indication

Outcome Measures

Primary Outcomes (2)

• Total Mortality

  Number of deaths observed

  Study duration (5.7 years mean follow-up)

• Death or Heart Failure Hospitalization

  Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization

  Study duration (5.7 years mean follow-up)

Secondary Outcomes (15)

• Death Due to Cardiovascular Causes

  Study duration (5.7 years mean follow-up)

• Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test

  12 months post-implant

• Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©

  12 months post-implant

• Incidence of Hospitalizations for Deterioration of Heart Failure

  Study duration (5.7 years mean follow-up)

• Incidence of Hospitalizations for Cardiovascular Events

  Study duration (5.7 years mean follow-up)

Study Arms (2)

RV Pacing

ACTIVE COMPARATOR

Standard Pacemaker implant

Device: RV Pacing

Biventricular Pacing

EXPERIMENTAL

Biventricular Pacemaker implant

Device: Biventricular Pacing

Interventions

Biventricular Pacing DEVICE

Biventricular Pacemaker implant

Biventricular Pacing

RV Pacing DEVICE

Standard Pacemaker implant

RV Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• nd degree AV-block type Mobitz II in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
• nd degree AV-block type Mobitz I (if indicated) in combination with 1st degree AV-block with a pQ-interval ≥ 220 ms or
• st 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

Klinikum der Philipps-Universität Marburg

Marburg, 35033, Germany

Location

Related Publications (3)

• Funck RC, Blanc JJ, Mueller HH, Schade-Brittinger C, Bailleul C, Maisch B; BioPace Study Group. Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the 'Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)' study. Europace. 2006 Aug;8(8):629-35. doi: 10.1093/europace/eul075.

  PMID: 16864616 BACKGROUND

• Funck RC, Mueller HH, Lunati M, Piorkowski C, De Roy L, Paul V, Wittenberg M, Wuensch D, Blanc JJ; BioPace study group. Characteristics of a large sample of candidates for permanent ventricular pacing included in the Biventricular Pacing for Atrio-ventricular Block to Prevent Cardiac Desynchronization Study (BioPace). Europace. 2014 Mar;16(3):354-62. doi: 10.1093/europace/eut343. Epub 2013 Nov 7.

  PMID: 24200715 BACKGROUND

• Funck RC, Muller HH, Lunati M, De Roy L, Klein N, Meisel E, Milasinovic G, Carlson MD, Wittenberg M, Hindricks G, Blanc JJ. Biventricular vs. right ventricular pacing devices in patients anticipated to require frequent ventricular pacing (BioPace). Europace. 2025 Mar 5;27(3):euaf029. doi: 10.1093/europace/euaf029.

  PMID: 40105785 DERIVED

MeSH Terms

Conditions

Atrioventricular Block; Ventricular Dysfunction

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Block; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Results Point of Contact

• Title: Pascale Ducloux, Clinical Manager
• Organization: St Jude Medical

pducloux@sjm.com

+3227746709

Study Officials

• Reinhard Funck, MD

  Klinikum Bad Hersfeld, Germany

  PRINCIPAL INVESTIGATOR

• Jean-Jacques Blanc, Prof.

  Hôpital Cavale Blanche, Brest, France

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: May 1, 2003
• Primary Completion: May 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 25, 2021
• Results First Posted: January 25, 2021

Record last verified: 2021-01

Locations

DE (1)