BACE-PACE-Trial - A multicenter study to investigate preventive pacing in combination with antiarrhythmic beta-blocker or AT-I-/angiotensin converting enzyme (ACE)-inhibitor therapy on the recurrence of atrial fibrillation (AF) in patients with dual-chamber pacemakers
| ISRCTN | ISRCTN78204941 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78204941 |
| Secondary identifying numbers | German Atrial Fibrillation Network B05 |
- Submission date
- 21/08/2005
- Registration date
- 12/10/2005
- Last edited
- 28/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Andreas Schuchert
Scientific
Scientific
University Heart Center
Martinistr. 52
Hamburg
20246
Germany
| Phone | +49 40 42803 5304 |
|---|---|
| schuchert@uke.uni-hamburg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | BACE-PACE-Trial - A multicenter study to investigate preventive pacing in combination with antiarrhythmic beta-blocker or AT-I-/angiotensin converting enzyme (ACE)-inhibitor therapy on the recurrence of atrial fibrillation (AF) in patients with dual-chamber pacemakers |
| Study acronym | BACE PACE |
| Study objectives | Comparison of AF-Burden in patients with paroxysmal atrial fibrillation (AF) and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDD[R]60-Stimulation or AF prevention pacing. All Patients were stratified according to their existing drug therapy e.g. Beta-Blocker or ACE-Inhibitor. Aim of the trial is to prove the inferiority concerning the efficacy of preventive pacing stimulation (PS) versus DDD[R]60-Standard stimulation (ST). Therefore AF burden at baseline is compared with both study groups. Responder is a AF patient with a relative AF burden >25% or absolute >1%, whereas the AF Burden at baseline phase must be greater than 1%. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Atrial fibrillation |
| Intervention | Participants are randomised either to preventive pacing stimulation or to DDD[R]60-Stimulation. Implantation of a triggered prevention pacemaker (Vitatron Selection 9000, Prevent AF, T 70 DR) 2-4 months before inclusion in the trial. |
| Intervention type | Other |
| Primary outcome measure | Total of patients with a significant reduction (>25%) of AF burden in the 6-months-follow-up-period |
| Secondary outcome measures | 1. AF Burden 2. Total of patients without AF recurrence 3. Efficacy of pharmacologic treatment in preventive stimulation 4. Time in sinus rhythm 5. Time until first AF recurrence 6. Onset-Mechanism with and without medication 7. Total of patients who have a benefit from preventive stimulation 8. Proportion of atrial and ventricular stimulation 9. Safety of the therapy |
| Overall study start date | 01/02/2005 |
| Completion date | 31/03/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 224 patients |
| Key inclusion criteria | 1. Idiopathic paroxysmal symptomatic atrial fibrillation 2. Implantation of a fully functional pacemaker (e.g. normal impedance, stimulation thresholds and sensing values) Vitatron Selection 9000, Prevent AF, T 70 DR 2-4 months ago, because of one of the following indications: symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome 3. Symptomatic sinuatrial block 4. High-grade AV-Block (AV Block II und III) 5. Binodal disease: Sick-Sinus-Syndrome and high-grade AV-Block 6. AV-Nodal-Ablation in combination with a pacemaker therapy ('Ablate & Pace') 7. Written informed consent of the patient 8. Age >18 years |
| Key exclusion criteria | 1. Chronic heart failure (New York Heart Association [NYHA] III/IV) 2. Acute myocardial infarction <6 months 3. Hypertrophic obstructive cardiomyopathy 4. Symptomatic hypo- or hyperthyreosis 5. Instable angina pectoris 6. Cardiogenic shock 7. Patients with diabetes mellitus and recurrence of hypoglycaemia 8. Pregnancy or breast feeding 9. Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted. 10. Reduced life expectancy (<6 months) 11. Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial 12. Evidence of an uncooperative attitude |
| Date of first enrolment | 01/02/2005 |
| Date of final enrolment | 31/03/2007 |
Locations
Countries of recruitment
- Germany
Study participating centre
University Heart Center
Hamburg
20246
Germany
20246
Germany
Sponsor information
German Atrial Fibrillation Network
Research organisation
Research organisation
Domagkstrasse 11
Münster
48149
Germany
| Phone | +49 251 83 45340 |
|---|---|
| Thomas.Weiss@ukmuenster.de | |
| Website | http://www.kompetenznetz-vorhofflimmern.de |
"ROR" |
https://ror.org/01spm3d88 |
Funders
Funder type
Industry
German Atrial Fibrillation Network (Germany)
No information available
Vitatron GmbH (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 31/12/2008 | 28/10/2021 | Yes | No |
Editorial Notes
28/10/2021: Publication reference added.
