Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

Meshalkin Research Institute of Pathology of Circulation

Status and phase: Completed; Phase 2

Conditions: Persistent Atrial Fibrillation

Treatments: Procedure: Ganglionated plexi ablation; Procedure: Pulmonary vein isolation; Procedure: Linear Lesion Ablation

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01703247

GP-LL-AF

Details and patient eligibility

About

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).

Enrollment: 264 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Persistent and longstanding persistent AF

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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264 participants in 2 patient groups

PVI+LL

Active Comparator group

Description:

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.

Treatment:

Procedure: Pulmonary vein isolation

Procedure: Linear Lesion Ablation

PVI+GP

Active Comparator group

Description:

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).

Treatment:

Procedure: Ganglionated plexi ablation

Procedure: Pulmonary vein isolation