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
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