Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
German Atrial Fibrillation Network Medtronic - Vitatron |
---|---|
Information provided by: | German Atrial Fibrillation Network |
ClinicalTrials.gov Identifier: | NCT00215761 |
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: | 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 |
Estimated Enrollment: | 224 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | July 2007 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Andreas Schuchert, Prof. Dr. | University Cardiac Center, Hamburg, Germany |
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 |
Atrial fibrillation Preventive stimulation Pacemaker |
Heart Diseases Atrial Fibrillation Recurrence Arrhythmias, Cardiac |
Pathologic Processes Cardiovascular Diseases |