Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196183
Status:
COMPLETED
Last Update Posted:
2008-03-18
First Post:
2005-09-12
Brief Title:
Trigger- vs Substrate-Ablation for Paroxysmal Atrial Fibrillation
Sponsor:
Deutsches Herzzentrum Muenchen
Organization:
Deutsches Herzzentrum Muenchen
Study Overview
Official Title:
Randomized Study Comparing Pulmonary Vein Isolation Alone vs Pulmonary Vein Isolation Plus Electrogram-Guided Substrate Ablation
Status:
COMPLETED
Status Verified Date:
2008-03
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:
The purpose of this study is to compare two strategies of catheter-based treatment of paroxysmal atrial fibrillation Pulmonary vein isolation either alone or combined with electrogram-guided substrate-ablation
Detailed Description:
Catheter ablation has evolved an accepted alternative in the curative treatment of atrial fibrillation AF However discussion about the best ablation strategy is still ongoing
In patients with paroxysmal AF it has been reproducibly demonstrated that curing rates of approximately 65-70 can be achieved with the electric isolation of pulmonary veins PV eliminating the initiating triggers of AF episodes Recently a new catheter ablation approach targeting in both atria fractionated complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described The first describer of this technique reports curing rates of 92 We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment
In patients with paroxysmal AF it has been reproducibly demonstrated that curing rates of approximately 65-70 can be achieved with the electric isolation of pulmonary veins PV eliminating the initiating triggers of AF episodes Recently a new catheter ablation approach targeting in both atria fractionated complex electrograms during ongoing AF and modifying thus the substrate maintaining AF has been described The first describer of this technique reports curing rates of 92 We want to compare in a randomized prospective study the treatment by PV isolation alone with a combined approach of PV isolation together with ablation of fractionated complex electrograms in patients with paroxysmal AF Study endpoint is the achievement of stable sinus rhythm as assessed by 7 days holter ECG in the absence of antiarrhythmic drug treatment
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