Atrioventricular BlockNCT00187278
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
A study testing Biventricular Pacing and RV Pacing in people with Atrioventricular Block and Ventricular Dysfunction, run by Abbott Medical Devices at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrioventricular Block, Ventricular Dysfunction
- What is being tested?
- Biventricular Pacing and RV Pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,833 participants
- Where
- 1 siteGermany
- Study dates
- May 2003to Oct 2014
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biventricular Pacing for Atrioventricular Block in Left Ventricular Dysfunction to Prevent Cardiac Desynchronization
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.
Read the 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.
- Conditions
- Atrioventricular Block, Ventricular Dysfunction
- Being tested
- Biventricular Pacing, RV Pacing
- Keywords
- Standard pacing indication
- Medical subject headings
- Atrioventricular Block, Ventricular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biventricular PacingDevice
Biventricular Pacemaker implant
RV PacingDevice
Standard Pacemaker implant
| Study group | Role | What they receive |
|---|---|---|
| RV Pacing | Active comparator | Standard Pacemaker implant Receives: Device: RV Pacing |
| Biventricular Pacing | Experimental | Biventricular Pacemaker implant Receives: Device: Biventricular Pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Mortality
Number of deaths observed
Measured: 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
Measured: Study duration (5.7 years mean follow-up)
Secondary outcomes (15)
Death Due to Cardiovascular Causes
Number of subjects who died due to cardiovascular causes, as classified by the independent Event Adjudication Committee (IEAC)
Measured: Study duration (5.7 years mean follow-up)
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Measured: 12 months post-implant
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.
Measured: 12 months post-implant
Incidence of Hospitalizations for Deterioration of Heart Failure
Measured: Study duration (5.7 years mean follow-up)
Incidence of Hospitalizations for Cardiovascular Events
Measured: Study duration (5.7 years mean follow-up)
Incidence of Hospitalizations for Any Reason
Measured: Study duration (5.7 years mean follow-up)
Cardiac Structure and Function
Measured: 12 & 24 months
Successful Implantation of the Left Ventricular Lead
Measured: Implantation
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.
Measured: Study duration (5.7 years mean follow-up)
Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test
Measured: 24 months post-implant
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.
Measured: 24 months post-implant
Duration of Hospitalizations for Deterioration of Heart Failure
Measured: Study Duration (5.7 years mean follow-up)
Duration of Hospitalizations for Cardiovascular Events
Measured: Study Duration (5.7 years mean follow-up)
Duration of Hospitalizations for Any Reason
Measured: Study duration (5.7 years mean follow-up)
Adverse Events Related to Left Ventricular Lead
Only serious adverse events related to the left ventricular lead are included.
Measured: Study Duration (5.7 years mean follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startMay 2003
- Primary completionMay 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrioventricular BlockStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,833 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reinhard Funck, MD, Principal investigator, Klinikum Bad Hersfeld, GermanyJean-Jacques Blanc, Prof., Study chair, Hôpital Cavale Blanche, Brest, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187278
- Sponsor's protocol ID
- CR03006HF
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2005
- Last updated
- 25 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16864616Funck 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.
PubMed 24200715Funck 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.
PubMed 40105785