Status:
WITHDRAWN
Catheter Ablation for Recently Diagnosed Paroxysmal Atrial Fibrillation
Lead Sponsor:
Valley Health System
Collaborating Sponsors:
Biosense Webster, Inc.
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
Phase:
PHASE4
Brief Summary
The objective is to compare the progression of Atrial Fib (AF) burden by continuous monitoring in patients with recently diagnosed paroxysmal AF treated by catheter ablation (PVI) versus anti-arrhythm...
Detailed Description
Randomized, multicenter clinical trial comparing medical therapy (Group I) with ablation therapy(Group II). Randomization will be determined by opening a sealed envelope. All patients will be implante...
Eligibility Criteria
Inclusion
- Patients with recently diagnosed paroxysmal AF who are eligible to receive specific rhythm control therapy
Exclusion
- Previous treatment with Class IC or class III AAD
- Previous AF ablation procedure
- Congestive heart failure (NYHA III-IV functional class)
- Left Ventricle ejection fraction less than 35%
- Left atrial diameter \> 55mm
- Unwillingness to participate
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01505296
Start Date
December 1 2011
End Date
January 1 2014
Last Update
December 16 2014
Active Locations (2)
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1
Valley Health System
Ridgewood, New Jersey, United States, 07450
2
State Research Institute of Circulation Pathology
Novosibirsk, Russia