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Recurrence of Atrial Fibrillation in Patients With Dual-Chamber Pacemakers and Drug Therapy
This study is currently recruiting participants.
Verified by German Atrial Fibrillation Network, September 2005
Sponsors and Collaborators: German Atrial Fibrillation Network
Medtronic - Vitatron
Information provided by: German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00215761
  Purpose

Comparison of AF-Burden in patients with paroxysmal atrial fibrillation 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.


Condition
Atrial Fibrillation

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome
U.S. FDA Resources
Study Type: Observational
Study Design: Natural History, Cross-Sectional, Defined Population, Prospective Study
Official Title: A Multicenter Study to Investigate Preventive Pacing in Combination With Antiarrhythmic Beta-Blocker Oder AT-I-/ACE-Inhibitor Therapy on the Recurrence of Atrial Fibrillation in Patients With Dual-Chamber Pacemakers

Further study details as provided by German Atrial Fibrillation Network:

Estimated Enrollment: 224
Study Start Date: January 2005
Estimated Study Completion Date: July 2007
Detailed Description:

Implantable pacemaker devices are available with specific atrial pacing algorithms designed to prevent atrial arrhythmias (Preventive stimulation). These algorithms work by increasing the atrial pacing rate to achieve continuous overdrive pacing or by responding to triggers such as premature atrial complexes.

Different investigation’s showed that preventive atrial pacing was associated with a 30 to 50 % reduction in the risk of recurrence of AF, compared with no pacing. But a complete recurrence-free long-term effect is not reached.

A hybrid therapy consisting of a combination of preventive atrial stimulation and pharmacologic therapy maybe useful in restoring sinus rhythm. The HOPE-(Heart Outcomes Prevention Evaluation)-Trial showed a overwhelming evidence that, in a broad range of high-risk patients, an ACE-Inhibitor (Ramipril) prevents cardiovascular death, stroke, and heart failure. AF leads to an activation of the renin-angiotensin system (RAS), which seems to play an important role in atrial remodelling. Both experimental and clinical data have confirmed the pro-arrhythmic role of the RAS and demonstrated an anti-arrhythmic effect of ACE- and AT-I-Inhibtors. Madrid et al. showed that a combination of the AT-I-Inhibitor irbesartan plus amiodarone decreased the rate of AF recurrences, with a dose-dependent effect, in AF patients. ACE- and AT-I-Inhibitors represent new and efficient therapeutical options to contrast the nearly inevitable progression of this arrhythmia towards its permanent form. Beta-Blockers are a common pharmacologic therapy in AF patients.

The aim of the BACE-PACE-Trial is to investigate preventive pacing stimulation (PS) vs. standard DDD[R]-60-Stimulation (ST) in combination with antiarrhythmic Beta-Blocker or ACE-inhibitor therapy on the recurrence of atrial fibrillation in patients with dual-chamber pacemakers

The Responder (patients without AF recurrence, respectively with a significant reduction in AF burden) are compared to the standardstimulation. A clinically relevance meant a reduction in AF burden of more than 25 % (experts consensus).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paroxysmal symptomatic atrial fibrillation
  • Implantation of a dual-chamber pacemaker because of generally accepted pacing indications
  • Symptomatic sinus bradycardia, sinus arrest, Tachy-Brady-Syndrome
  • Symptomatic sinuatrial block
  • Advanced AV-block (AV block II / III)
  • Binodal disease: Sick-sinus-syndrome and advanced AV-block
  • AV-Nodal-Ablation in combination with pacemaker therapy ( „Ablate & Pace“).
  • The implantation of a fully functional DDDR Selection 9000, Prevent AF, T 70 DR pacemaker (Vitatron) e.g. normal impedance, stimulation thresholds and sensing values) 2 – 4 months after implantation
  • Written informed consent of the patient
  • Age > 18 years

Exclusion Criteria:

  • Chronic heart failure (NYHA III/IV)
  • Acute myocardial infarction < 6 months
  • Hypertrophic obstructive cardiomyopathy
  • Symptomatic hypo- or hyperthyroidism
  • Instable angina pectoris
  • Cardiogenic shock
  • Patients with diabetes mellitus and recurrent hypoglycaemia
  • Pregnancy or breast feeding
  • Participation in a clinical trial within the last 30 days. Simultaneous participation in a registry (e.g. project AB1 of the AFNET) is permitted
  • Reduced life expectancy (< 6 months)
  • Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical trial
  • Evidence of an uncooperative attitude
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00215761

Contacts
Contact: Andreas Schuchert, Prof. Dr. +49-40-4280 ext 5304 schuchert@uke.uni-hamburg.de
Contact: Boris A Lutomsky, Dr. +49-40-42803 ext 4179 lutomsky@uke.uni-hamburg.de

Locations
Germany
University Cardiac Center Recruiting
Hamburg, Germany, 20246
Contact: Andreas Schuchert, Prof. Dr.     +49-40-42803 ext 5304     schuchert@uke.uni-hamburg.de    
Contact: Boris A Lutomsky, Dr.     +49-40-4280 ext 4179     lutomsky@uke.uni-hamburg.de    
Sponsors and Collaborators
German Atrial Fibrillation Network
Medtronic - Vitatron
Investigators
Principal Investigator: Andreas Schuchert, Prof. Dr. University Cardiac Center, Hamburg, Germany
  More Information

German Atrial Fibrillation Network  This link exits the ClinicalTrials.gov site

Study ID Numbers: AFNET-B05
Study First Received: September 14, 2005
Last Updated: September 14, 2005
ClinicalTrials.gov Identifier: NCT00215761  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Atrial Fibrillation Network:
Atrial fibrillation
Preventive stimulation
Pacemaker

Study placed in the following topic categories:
Heart Diseases
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009