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Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01703247
First Posted: October 10, 2012
Last Update Posted: October 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Meshalkin Research Institute of Pathology of Circulation
  Purpose
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 Intervention Phase
Persistent Atrial Fibrillation Procedure: Pulmonary vein isolation Procedure: Ganglionated plexi ablation Procedure: Linear Lesion Ablation Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Meshalkin Research Institute of Pathology of Circulation:

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

Enrollment: 264
Study Start Date: January 2008
Study Completion Date: May 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
  Contacts and Locations
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
  More Information

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 Submitted: October 5, 2012
First Posted: October 10, 2012
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