Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00215761
Status:
COMPLETED
Last Update Posted:
2012-09-10
First Post:
2005-09-14
Brief Title:
Recurrence of Atrial Fibrillation in Patients With Dual-chamber Pacemakers and Drug Therapy
Sponsor:
Atrial Fibrillation Network
Organization:
Atrial Fibrillation Network
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Comparison of AF-Burden in patients with paroxysmal atrial fibrillation and the necessity of a Dual-Chamber-Pacemaker-Therapy either with a DDDR60-Stimulation or AF prevention pacing All Patients were stratified according to their existing drug therapy eg Beta-Blocker or ACE-Inhibitor
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 investigations 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 DDDR-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
Different investigations 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 DDDR-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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None