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

Ventricular Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187278
• Other study ID #: CR03006HF
• Status: Completed
• Phase: N/A
• Start date: May 2003
• Est. completion date: October 2014

Study information

• Verified date: January 2021
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1833
• Est. completion date: October 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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:

1. Permanent 3rd degree atrioventricular (AV)-block or

2. Intermittent 3rd degree AV-block in combination with 1st degree AV-block with a pQ-interval = 220 ms or

3. 2nd degree AV-block type Mobitz II in combination with 1st degree AV-block with a pQ-interval = 220 ms or

4. 2nd degree AV-block type Mobitz I (if indicated) in combination with 1st degree AV-block with a pQ-interval = 220 ms or

5. 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

6. 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

7. Chronic (permanent) atrial fibrillation (flutter or tachycardia) with a spontaneous heart (ventricular) rate at rest = 60/min or

8. 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)

9. Patients scheduled for AV node ablation

2. Any QRS duration and morphology

3. 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)

4. 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

5. Willingness and ability to comply with the prescribed follow-up tests and schedule of evaluations.

6. Absence of an implanted ventricular pacing device (patients with atrial pacemakers and new need for ventricular pacing may be included)

Exclusion Criteria:

1. 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.

2. Implanted ventricular pacing device

3. 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)

4. Evidence of acute left ventricular dysfunction and high probability for its reversibility (e.g. acute myocarditis, tachycardiomyopathy)

5. Implanted prosthetic tricuspid valve

6. Severe musculoskeletal disorder(s)

7. Age below 18 years

8. Current or planned pregnancy in the next 6 months

9. Current or recent (within the past 30 days) participation in any other clinical investigation

10. Life expectancy of less than 6 months

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

Related Conditions & MeSH terms

• Atrioventricular Block
• Ventricular Dysfunction

Intervention

Device:
• Biventricular Pacing
Biventricular Pacemaker implant
• RV Pacing
Standard Pacemaker implant

Locations

Country	Name	City	State
Germany	Klinikum der Philipps-Universität Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Mortality	Number of deaths observed	Study duration (5.7 years mean follow-up)
Primary	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	Death Due to Cardiovascular Causes	Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)	Study duration (5.7 years mean follow-up)
Secondary	Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test		12 months post-implant
Secondary	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.	12 months post-implant
Secondary	Incidence of Hospitalizations for Deterioration of Heart Failure		Study duration (5.7 years mean follow-up)
Secondary	Incidence of Hospitalizations for Cardiovascular Events		Study duration (5.7 years mean follow-up)
Secondary	Incidence of Hospitalizations for Any Reason		Study duration (5.7 years mean follow-up)
Secondary	Cardiac Structure and Function		12 & 24 months
Secondary	Successful Implantation of the Left Ventricular Lead		Implantation
Secondary	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.	Study duration (5.7 years mean follow-up)
Secondary	Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test		24 months post-implant
Secondary	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.	24 months post-implant
Secondary	Duration of Hospitalizations for Deterioration of Heart Failure		Study Duration (5.7 years mean follow-up)
Secondary	Duration of Hospitalizations for Cardiovascular Events		Study Duration (5.7 years mean follow-up)
Secondary	Duration of Hospitalizations for Any Reason		Study duration (5.7 years mean follow-up)
Secondary	Adverse Events Related to Left Ventricular Lead	Only serious adverse events related to the left ventricular lead are included.	Study Duration (5.7 years mean follow-up)