Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

NCT01703247 — Phase 2, Completed, 264 participants, Meshalkin Research Institute of Pathology of Circulation

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Ganglionated Plexi Ablation vs Linear Ablation in Patients Undergoing Pulmonary Vein Isolation for Persistent/Longstanding Persistent Atrial Fibrillation: A Randomized Comparison

Registry	NCT01703247
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	264 (Actual)
Sponsor	Meshalkin Research Institute of Pathology of Circulation (Network)
Conditions	Persistent Atrial Fibrillation
Interventions	Pulmonary vein isolation, Ganglionated plexi ablation, Linear Lesion Ablation (Procedure)
Dates	start 2008-01-01, primary completion 2009-01-01, completion 2009-05-01, first posted 2012-10-10, last updated 2012-10-10
Locations	1 site in Russia

-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).

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+Arms and interventions

Arm	Type	Interventions	Description
PVI+LL	Active comparator	Procedure: Pulmonary vein isolation; Procedure: 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	Active comparator	Procedure: Pulmonary vein isolation; Procedure: 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).

Pulmonary vein isolation (Procedure)
Ganglionated plexi ablation (Procedure)
Linear Lesion Ablation (Procedure)

+Outcome measures

Primary outcomes

freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia [3 years]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

* Persistent and longstanding persistent AF

Exclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
State Research Institute of CIrculation Pathology	Novosibirsk	Russia

+Investigators

Evgeny Pokushalov, MD, PhD, Principal investigator, State Research Institute of Circulation Pathology