Condition category
Circulatory System
Date applied
21/08/2005
Date assigned
12/10/2005
Last edited
06/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Andreas Schuchert

ORCID ID

Contact details

University Heart Center
Martinistr. 52
Hamburg
20246
Germany
+49 40 42803 5304
schuchert@uke.uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

German Atrial Fibrillation Network B05

Study information

Scientific title

Acronym

BACE PACE

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%.

Ethics approval

Not provided at time of registration.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/02/2005

Overall trial end date

31/03/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

224 patients

Participant 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

Recruitment start date

01/02/2005

Recruitment end date

31/03/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University Heart Center
Hamburg
20246
Germany

Sponsor information

Organisation

German Atrial Fibrillation Network

Sponsor details

Domagkstrasse 11
Münster
48149
Germany
+49 251 83 45340
Thomas.Weiss@ukmuenster.de

Sponsor type

Research organisation

Website

http://www.kompetenznetz-vorhofflimmern.de

Funders

Funder type

Industry

Funder name

German Atrial Fibrillation Network (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Vitatron GmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes