Pulmonary Vein Isolation To Reduce Future Risk Of Atrial Fibrillation In Patients Undergoing Typical Flutter (REDUCE AF)
The purpose is to compare long term occurrence of atrial arrhythmias including atrial fibrillation (AF) and thromboembolic complications including cerebrovascular events (CVE) in patients with typical atrial flutter (AFLT) undergoing cavo-tricuspid isthmus (CTI) ablation alone versus CTI ablation combined with pulmonary vein isolation (PVI).
Patients With Typical Aflutter and Manifest Risk Factors With Future Development of AF.
Procedure: CTI ablation alone
Procedure: CTI ablation and Pulmonary vein isolation (PVI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Randomized Trial Comparing Long Term Occurrence of Atrial Arrhythmias Including Atrial Fibrillation (AF) and Thromboembolic Complications in Patients With Typical Atrial Flutter (AFLT) Undergoing Cavo-tricuspid Isthmus (CTI) Ablation Alone Versus CTI Ablation Combined With Pulmonary Vein Isolation (PVI).|
- Primary: 1) Long-term (~2 year) freedom from atrial arrhythmias (AFLT and / or AF) and thromboembolic events (including CVEs). [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Occurrence of serious adverse events [CVE, pericardial effusion results in tamponade, development of PV stenosis (symptomatic or asymptomatic >70% reduction in PV diameter in ≥1 veins assessed by CT scan), left atrial-esophageal fistula and death [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Long term (~2 year) use of membrane stabilizing antiarrhythmic drugs. Long term (~2 year) use of oral anticoagulation. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Placebo Comparator: CTI ablation only
subjects undergoing cavo-tricuspid isthmus (CTI) ablation alone for Aflutter
|Procedure: CTI ablation alone|
Active Comparator: CTI ablation and PVI.
subjects undergoing cavo-tricuspid isthmus (CTI) ablation for Aflutter and pulmonary vein isolation (PVI) for Atrial Fibrillation.
|Procedure: CTI ablation and Pulmonary vein isolation (PVI)|
Typical Atrial Flutter (AFLT) is a common cardiac arrhythmia. Studies have demonstrated the safety and superiority of ablation procedure over antiarrhythmic drug (AAD) therapy. Long term freedom from typical AFLT has been consistently shown after successful ablation, but up to 30% of these patients can experience new onset of a different arrhythmia i.e., Atrial Fibrillation (AF). AF results from triggers in the back of the left upper chamber in the heart (left atrium - LA). These triggers typically arise from in and around the opening of the 4 veins (pulmonary veins - PVs) that bring blood from the lungs into the heart. The highest incidence of AF in patients undergoing ablation for typical AFLT was observed where the follow-up duration exceeded a year after the AFLT ablation. This would suggest that AF development in patients undergoing typical AFLT ablation is progressive and inevitable.
|Contact: Mary Gnap||215 349 email@example.com|
|United States, Pennsylvania|
|Hospital of the University of Pennsylvania||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Sanjay Dixit, MD firstname.lastname@example.org|
|Principal Investigator: Sanjay Dixit, MD|
|Principal Investigator:||Sanjay Dixit, MD||University of Pennsylvania|