"UNMASKING Study" For Atrial Fibrillation Recurrences Typing in Early Postoperative Period

Phase 3

Completed

• Conditions: Atrial Fibrillation
• Interventions: Procedure: Circumferential PVI and subcutaneous cardiac monitor implantation

• 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

Study Timeline

• Study Start: 2008-02
• Primary Completion: 2010-02
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-15
• Study First Posted: 2010-07-16
• Study Completion: 2010-11
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-23
• Last Update Posted: 2012-04-24

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

Arm && Interventions

Group	Intervention	Description
Group 1 (no early recurrence)	Circumferential PVI and subcutaneous cardiac monitor implantation	Patients without atrial fibrillation recurrences through the implantable cardiac monitors during the 3 months post-ablation period.
Group 2 (early AF recurrence)	Circumferential PVI and subcutaneous cardiac monitor implantation	Patients with AF recurrences documented by the ICM during the 3 months post-ablation period.
Group 3 (early recurrence-no reablation)	Circumferential PVI and subcutaneous cardiac monitor implantation	Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 would not receive reablation.
Group 4 (early recurrence-early reablation)	Circumferential PVI and subcutaneous cardiac monitor implantation	Patients with AF recurrences documented by the ICM during the 3 months post-ablation period from Group 2 will receive early reablation based on data stored by implanted monitor.

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