Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392054
Status:
COMPLETED
Last Update Posted:
2020-01-31
First Post:
2006-10-23
Brief Title:
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment The RAAFT Study
Sponsor:
Population Health Research Institute
Organization:
Population Health Research Institute
Study Overview
Official Title:
First Line Radiofrequency Ablation Versus Antiarrhythmic Drugs for Atrial Fibrillation Treatment A Multi-center Randomized Trial
Status:
COMPLETED
Status Verified Date:
2020-01
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:
RAAFT
Brief Summary:
The purpose of this study is to determine whether catheter-based pulmonary vein isolation is superior to antiarrhythmic drugs as first line therapy in patients with symptomatic paroxysmal recurrent atrial fibrillation not previously treated with therapeutic doses of antiarrhythmic drugs
Detailed Description:
Atrial fibrillation AF is the most common arrhythmia encountered in clinical practice and is estimated to affect 22 million people in the United States AF is a major cause of stroke adversely affects quality of life and is associated with increased mortality Despite advances in antiarrhythmic drug therapy AF continues to be associated with significant morbidity Although antiarrhythmic drug therapy is currently considered a first-line option recent data indicate that more than 35 of Patients will have recurrence of AF despite best antiarrhythmic drug AAD therapy and more than 30 of Patients will discontinue the drugs because of adverse reactions Furthermore although recent trials have indicated equivalence of rhythm and rate control strategies in some patient populations 25-35 of Patients with AF who are rate controlled will continue to have activity limiting symptoms Newer measures to prevent treat and potentially cure AF are needed Seminal work by Haissaguerre and replicated by Chen showed that the majority of AF is initiated by ectopic foci found primarily in the pulmonary veins PV Experience with the catheter-based Maze technique led to observations that opened the door to effective and practical catheter-based cures for AF In response to the difficulties of focal ablation an alternate strategy has been developed that seeks to electrically isolate the Pulmonary Veins from the atrial tissue Empirical PV isolation targets all of the PVs without regard to the initiation of ectopic beats The goal is to create entrance block in the PV Multipolar circular catheters and basket catheters have been developed that facilitate identification of the electrical connections that are present at the junction of the atrium and the PV and radiofrequency energy is applied in a circumferential fashion until entrance block is achieved Relative to focal ablation circumferential PV isolation is simpler to perform can be completed without inducing AF has a shorter procedure time and has a lower incidence of PV stenosis
Comparison Patients will have ablation to achieve entrance andor exit block into all pulmonary veins compared with patients receiving antiarrhythmic drugs given in accordance with ACCAHAESC 2006 Guidelines for the Management of patients with AF
Comparison Patients will have ablation to achieve entrance andor exit block into all pulmonary veins compared with patients receiving antiarrhythmic drugs given in accordance with ACCAHAESC 2006 Guidelines for the Management of patients with AF
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