"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period
Phase 3
Completed
- Conditions
- Atrial Fibrillation
- Registration Number
- NCT01164319
- Lead Sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Brief Summary
The aim of this study is to identify the most appropriate method for managing patients with AF recurrences after the first ablation procedure, through the diagnostic data stored by a subcutaneous AF monitor.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- highly symptomatic patients refractory to at least two antiarrhythmic drugs
- patients with sustained PAF episodes and/or history of PersAF interrupted with cardioversion.
Exclusion Criteria
- congestive heart failure
- ejection fraction <35%
- left atrial diameter >60 mm
- previous ablation procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Freedom from atrial fibrillation or atrial flutter/tachycardia in Group 4 vs Group 3 12 months
- Secondary Outcome Measures
Name Time Method Freedom from AF in each group and the comparison of any group to each other 12 months
Trial Locations
- Locations (1)
State Research Institute of CIrculation Pathology
🇷🇺Novosibirsk, Russian Federation
State Research Institute of CIrculation Pathology🇷🇺Novosibirsk, Russian Federation