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Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

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ClinicalTrials.gov Identifier: NCT01703247
Recruitment Status : Completed
First Posted : October 10, 2012
Last Update Posted : October 10, 2012
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Persistent Atrial Fibrillation Procedure: Pulmonary vein isolation Procedure: Ganglionated plexi ablation Procedure: Linear Lesion Ablation Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ganglionated Plexi Ablation vs Linear Ablation in Patients Undergoing Pulmonary Vein Isolation for Persistent/Longstanding Persistent Atrial Fibrillation: A Randomized Comparison
Study Start Date : January 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PVI+LL
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.
Procedure: Pulmonary vein isolation
Procedure: Linear Lesion Ablation
Active Comparator: PVI+GP
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).
Procedure: Pulmonary vein isolation
Procedure: Ganglionated plexi ablation



Primary Outcome Measures :
  1. freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia [ Time Frame: 3 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent and longstanding persistent AF

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703247


Locations
Russian Federation
State Research Institute of CIrculation Pathology
Novosibirsk, Russian Federation, 630055
Sponsors and Collaborators
Meshalkin Research Institute of Pathology of Circulation
Investigators
Principal Investigator: Evgeny Pokushalov, MD, PhD State Research Institute of Circulation Pathology

Additional Information:
Responsible Party: Meshalkin Research Institute of Pathology of Circulation
ClinicalTrials.gov Identifier: NCT01703247     History of Changes
Other Study ID Numbers: GP-LL-AF
First Posted: October 10, 2012    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012

Keywords provided by Meshalkin Research Institute of Pathology of Circulation:
Arrhythmias
Ablation

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes