Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00224341
Status:
UNKNOWN
Last Update Posted:
2006-10-18
First Post:
2005-09-20
Brief Title:
Arrhythmia Restart Prevention and RatE STabilization in Atrial Fibrillation
Sponsor:
Vitatron France
Organization:
Vitatron France
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
The objective of this trial is to show the therapeutic efficacy of the preventive pacing therapies of the Selection 9000 and Vitatron T70 DR pacemakers dedicated to handle atrial fibrillation AF Two new algorithms post-AF response and ventricular rate stabilization VRS will be assessed in a combined pathway compared to a control group The efficacy of the overall available therapies to prevent AF and its symptoms will then be assessed also
Detailed Description:
Due to anti-arrhythmic pharmacological drugs failure to suppress atrial fibrillation AF interest towards preventive pacing treatments is increasing The importance of this option in the panoply of the preventive tools is fully justified only by considering the insufficiency the complexity or the poor reproducibility of the other non-pharmaceutical approaches
Preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies and more generally by stabilizing atrial tissue when potential triggers are appearing
On top of that cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools in terms of sensitivity specificity and continuity in the monitoring
Four preventive pacing therapies have already been evaluated the objective of this study is to show the clinical benefit brought by the new features of the Selection 9000 Vitatron T70 DR
Preventive pacing therapies rely on their potential effect on different onset modalities emphasized by previous studies and more generally by stabilizing atrial tissue when potential triggers are appearing
On top of that cardiac stimulator can deliver these therapies when identifying these triggers but also can offer incomparable diagnostic tools in terms of sensitivity specificity and continuity in the monitoring
Four preventive pacing therapies have already been evaluated the objective of this study is to show the clinical benefit brought by the new features of the Selection 9000 Vitatron T70 DR
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