Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers and Drug Therapy

This study has been completed.
Sponsor:
Collaborator:
Medtronic BRC
Information provided by (Responsible Party):
German Atrial Fibrillation Network
ClinicalTrials.gov Identifier:
NCT00215761
First received: September 14, 2005
Last updated: September 7, 2012
Last verified: September 2012
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by German Atrial Fibrillation Network:

Enrollment: 263
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
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 remodeling. 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-Inhibitors. 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 standard stimulation. 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
Sampling Method:   Probability Sample
Study Population

Paroxysmal symptomatic atrial fibrillation with implemented dual-chamber pacemakers

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00215761

Locations
Germany
University Cardiac Center
Hamburg, Germany, 20246
Sponsors and Collaborators
German Atrial Fibrillation Network
Medtronic BRC
Investigators
Principal Investigator: Andreas Schuchert, Prof. Dr. University Cardiac Center, Hamburg, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: German Atrial Fibrillation Network
ClinicalTrials.gov Identifier: NCT00215761     History of Changes
Other Study ID Numbers: AFNET-B05
Study First Received: September 14, 2005
Last Updated: September 7, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Atrial Fibrillation
Recurrence
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on July 23, 2014