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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | |
| Public 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 |
| Scientific title | |
| Acronym | BACE PACE |
| Serial number at source | German Atrial Fibrillation Network B05 |
| Study hypothesis |
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%. |
| Lay summary | |
| Ethics approval | Not provided at time of registration. |
| Study design | Randomised controlled trial |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Atrial fibrillation |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/02/2005 |
| Anticipated end date | 31/03/2007 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 224 patients |
| Interventions |
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. |
| Primary outcome measure(s) | Total of patients with a significant reduction (>25%) of AF burden in the 6-months-follow-up-period |
| Secondary outcome measure(s) |
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 |
| Sources of funding |
German Atrial Fibrillation Network (Germany)
Vitatron GmbH (Germany) |
| Trial website | |
| Publications | |
| Contact name | Prof Andreas Schuchert |
| Address |
University Heart Center
Martinistr. 52 |
| City/town | Hamburg |
| Zip/Postcode | 20246 |
| Country | Germany |
| Tel | +49 40 42803 5304 |
| Fax | +49 40 42803 5766 |
| schuchert@uke.uni-hamburg.de | |
| Sponsor | German Atrial Fibrillation Network |
| Address | Domagkstrasse 11 |
| City/town | Münster |
| Zip/Postcode | 48149 |
| Country | Germany |
| Tel | +49 251 83 45340 |
| Fax | +49 251 83 45343 |
| Thomas.Weiss@ukmuenster.de | |
| Sponsor website: | http://www.kompetenznetz-vorhofflimmern.de |
| Date applied | 21/08/2005 |
| Last edited | 06/08/2007 |
| Date ISRCTN assigned | 12/10/2005 |
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| © 2012 ISRCTN unless otherwise stated. | |
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