Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

Phase 2

Completed

• Conditions: Persistent Atrial Fibrillation
• Interventions: Procedure: Pulmonary vein isolation; Procedure: Linear Lesion Ablation; Procedure: Ganglionated plexi ablation

• 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

Arm && Interventions

Group	Intervention	Description
PVI+LL	Pulmonary vein isolation	Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
PVI+LL	Linear Lesion Ablation	Circumferential PVI was accomplished and then additional ablation lines were created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the LA between the two superior PVs (roof). Finally, patients underwent cavo-tricuspid isthmus ablation in the right atrium.
PVI+GP	Pulmonary vein isolation	To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).
PVI+GP	Ganglionated plexi ablation	To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).

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