N/A
N=1,833
Biopace Study: Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization
Atrioventricular Block · Ventricular Dysfunction
Bottom Line
View on ClinicalTrials.gov: NCT00187278 ↗Enrolled (actual)
1,833
Serious AEs
74.0%
Results posted
Jan 2021
Primary outcome: Primary: Total Mortality — 307; 305 Participants — p=0.3492
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Biventricular Pacing (Device); RV Pacing (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Mortality |
307; 305 | 0.3492 |
| PRIMARY Death or Heart Failure Hospitalization |
346; 363 | 0.0882 |
| SECONDARY Death Due to Cardiovascular Causes |
106; 107 | 0.8215 |
| SECONDARY Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test |
369.3; 376.5 | — |
| SECONDARY Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© |
17.5; 17.3 | — |
| SECONDARY Incidence of Hospitalizations for Deterioration of Heart Failure |
0.043; 0.037 | — |
| SECONDARY Incidence of Hospitalizations for Cardiovascular Events |
0.162; 0.161 | — |
| SECONDARY Incidence of Hospitalizations for Any Reason |
0.392; 0.432 | — |
| SECONDARY Cardiac Structure and Function |
— | — |
| SECONDARY Successful Implantation of the Left Ventricular Lead |
760 | — |
| SECONDARY Chronic Atrial Fibrillation (Defined as Presence of Atrial Fibrillation in Two Subsequent ECG´s/Visits) |
91; 76 | — |
| SECONDARY Functional Capacity as Measured by the Distance Covered in the 6-minute Walk Test |
369.3; 376.5 | — |
| SECONDARY Health Related Quality of Life Measured by the Minnesota Living With Heart Failure Questionnaire© |
17.5; 17.3 | — |
| SECONDARY Duration of Hospitalizations for Deterioration of Heart Failure |
0.40; 0.39 | — |
| SECONDARY Duration of Hospitalizations for Cardiovascular Events |
1.52; 1.50 | — |
| SECONDARY Duration of Hospitalizations for Any Reason |
3.72; 4.14 | — |
| SECONDARY Adverse Events Related to Left Ventricular Lead |
1; 38 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00187278). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.