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

Primary Purpose

Atrioventricular Block, Ventricular Dysfunction

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Biventricular Pacing
RV Pacing
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrioventricular Block focused on measuring Standard pacing indication

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinikum der Philipps-Universität Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RV Pacing

Biventricular Pacing

Arm Description

Standard Pacemaker implant

Biventricular Pacemaker implant

Outcomes

Primary Outcome Measures

Total Mortality
Number of deaths observed
Death or Heart Failure Hospitalization
Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization

Secondary Outcome Measures

Death Due to Cardiovascular Causes
Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Incidence of Hospitalizations for Deterioration of Heart Failure
Incidence of Hospitalizations for Cardiovascular Events
Incidence of Hospitalizations for Any Reason
Cardiac Structure and Function
Successful Implantation of the Left Ventricular Lead
Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits)
Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits.
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Duration of Hospitalizations for Deterioration of Heart Failure
Duration of Hospitalizations for Cardiovascular Events
Duration of Hospitalizations for Any Reason
Adverse Events Related to Left Ventricular Lead
Only serious adverse events related to the left ventricular lead are included.

Full Information

First Posted
September 13, 2005
Last Updated
January 5, 2021
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT00187278
Brief Title
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
Official Title
Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrioventricular Block, Ventricular Dysfunction
Keywords
Standard pacing indication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1833 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RV Pacing
Arm Type
Active Comparator
Arm Description
Standard Pacemaker implant
Arm Title
Biventricular Pacing
Arm Type
Experimental
Arm Description
Biventricular Pacemaker implant
Intervention Type
Device
Intervention Name(s)
Biventricular Pacing
Intervention Description
Biventricular Pacemaker implant
Intervention Type
Device
Intervention Name(s)
RV Pacing
Intervention Description
Standard Pacemaker implant
Primary Outcome Measure Information:
Title
Total Mortality
Description
Number of deaths observed
Time Frame
Study duration (5.7 years mean follow-up)
Title
Death or Heart Failure Hospitalization
Description
Number of subjects who experienced death or hospitalization where heart failure is a primary cause of hospitalization
Time Frame
Study duration (5.7 years mean follow-up)
Secondary Outcome Measure Information:
Title
Death Due to Cardiovascular Causes
Description
Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)
Time Frame
Study duration (5.7 years mean follow-up)
Title
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Time Frame
12 months post-implant
Title
Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Description
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 12 months MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Time Frame
12 months post-implant
Title
Incidence of Hospitalizations for Deterioration of Heart Failure
Time Frame
Study duration (5.7 years mean follow-up)
Title
Incidence of Hospitalizations for Cardiovascular Events
Time Frame
Study duration (5.7 years mean follow-up)
Title
Incidence of Hospitalizations for Any Reason
Time Frame
Study duration (5.7 years mean follow-up)
Title
Cardiac Structure and Function
Time Frame
12 & 24 months
Title
Successful Implantation of the Left Ventricular Lead
Time Frame
Implantation
Title
Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits)
Description
Chronic atrial fibrillation is defined as presence of atrial fibrillation in two subsequent ECG´s/visits.
Time Frame
Study duration (5.7 years mean follow-up)
Title
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Time Frame
24 months post-implant
Title
Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire©
Description
Minnesota Living with Heart Failure (MLWHF) questionnaire score at 24 months. MLWHF score: the total scale is from 0 to 105, with higher scores indicating worse health status.
Time Frame
24 months post-implant
Title
Duration of Hospitalizations for Deterioration of Heart Failure
Time Frame
Study Duration (5.7 years mean follow-up)
Title
Duration of Hospitalizations for Cardiovascular Events
Time Frame
Study Duration (5.7 years mean follow-up)
Title
Duration of Hospitalizations for Any Reason
Time Frame
Study duration (5.7 years mean follow-up)
Title
Adverse Events Related to Left Ventricular Lead
Description
Only serious adverse events related to the left ventricular lead are included.
Time Frame
Study Duration (5.7 years mean follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reinhard Funck, MD
Organizational Affiliation
Klinikum Bad Hersfeld, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jean-Jacques Blanc, Prof.
Organizational Affiliation
Hôpital Cavale Blanche, Brest, France
Official's Role
Study Chair
Facility Information:
Facility Name
Klinikum der Philipps-Universität Marburg
City
Marburg
ZIP/Postal Code
35033
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
16864616
Citation
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.
Results Reference
background
PubMed Identifier
24200715
Citation
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.
Results Reference
background

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

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