Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

Phase 2

Completed

• Conditions: Persistent Atrial Fibrillation

• Registration Number: NCT01703247
• Lead Sponsor: Meshalkin Research Institute of Pathology of Circulation

Brief Summary

The investigators have conducted a prospective, double-blind, randomized study to assess the comparative safety and efficacy of two different ablation strategies, PVI plus linear lesions (LL) versus PVI plus GP ablation, in patients with persistent or longstanding persistent AF. Results were assessed after follow-up of at least 3 years with the use of an implanted monitoring device (IMD).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2009-01
• Study Completion: 2009-05
• Status Verified: 2012-10
• Study First Submitted: 2012-10-05
• Study First Submitted QC: 2012-10-09
• Last Update Submitted: 2012-10-09
• Study First Posted: 2012-10-10
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

• Persistent and longstanding persistent AF

Exclusion Criteria

• congestive heart failure
• LV ejection fraction < 35%
• left atrial diameter > 60 mm

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia	3 years

Trial Locations

Locations (1)

State Research Institute of CIrculation Pathology; 🇷🇺 Novosibirsk, Russian Federation