Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00259623
Status:
COMPLETED
Last Update Posted:
2009-07-17
First Post:
2005-11-25
Brief Title:
Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients Efficacy at 3 Months
Sponsor:
University Hospital Toulouse
Organization:
University Hospital Toulouse
Study Overview
Official Title:
Efficacy at 3 Months on Permanent Atrial Fibrillation in Patients Candidates to Cardiac Surgical Treatment by Epicardial or Possibly Endocardial Radiofrequency Ablation
Status:
COMPLETED
Status Verified Date:
2009-07
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 objective of the study is to evaluate the efficacy of the epicardial or endocardial radiofrequency ablation in the treatment of atrial fibrillation
It is a multicentric prospective randomized parallel comparative double blind study The study principal objective is to evaluate the absence of atrial fibrillation after 3 months The secondary objectives consist in the evaluation of the maintenance of the sinusal heart rate at one year and of the quality of life improvement
It is a multicentric prospective randomized parallel comparative double blind study The study principal objective is to evaluate the absence of atrial fibrillation after 3 months The secondary objectives consist in the evaluation of the maintenance of the sinusal heart rate at one year and of the quality of life improvement
Detailed Description:
Principal objective
To evaluate the efficacy at 3 months of combined ablation technique in the treatment of chronic atrial fibrillation during cardiac surgery in order to obtain a sinusal heart rate
A sequential statistical analysis of the results will be performed every 10 patients
In case of validation of the principal objective by a sequential method ie proving the superiority of the treatment by ablation the study would then be opened and pursued by using the ablation technique for all subsequent patients in order to validate the secondary study objectives
Secondary objectives
To evaluate the quality of life of the patients at one year and the absence of atrial fibrillation relapse
6 and 12 months clinical follow-up
To evaluate the left atrial function at 6 months by trans-oesophagus echocardiography
To evaluate the efficacy at 3 months of combined ablation technique in the treatment of chronic atrial fibrillation during cardiac surgery in order to obtain a sinusal heart rate
A sequential statistical analysis of the results will be performed every 10 patients
In case of validation of the principal objective by a sequential method ie proving the superiority of the treatment by ablation the study would then be opened and pursued by using the ablation technique for all subsequent patients in order to validate the secondary study objectives
Secondary objectives
To evaluate the quality of life of the patients at one year and the absence of atrial fibrillation relapse
6 and 12 months clinical follow-up
To evaluate the left atrial function at 6 months by trans-oesophagus echocardiography
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOL | None | None | None |