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NCT01703247 Clinical Trial

Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

Persistent Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01703247
Other study ID # GP-LL-AF
Secondary ID
Status Completed
Phase Phase 2
First received October 5, 2012
Last updated October 9, 2012
Start date January 2008
Est. completion date May 2009

Study information
Verified date October 2012
Source Meshalkin Research Institute of Pathology of Circulation
Contact n/a
Is FDA regulated No
Health authority Russia: Ethics Committee
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 264
Est. completion date May 2009
Est. primary completion date January 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Persistent and longstanding persistent AF

Exclusion Criteria:

- congestive heart failure

- LV ejection fraction < 35%

- left atrial diameter > 60 mm

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Pulmonary vein isolation

• Ganglionated plexi ablation

• Linear Lesion Ablation

Locations
Country Name City State
Russian Federation State Research Institute of CIrculation Pathology Novosibirsk

Sponsors (1)
Lead Sponsor Collaborator
Meshalkin Research Institute of Pathology of Circulation

Country where clinical trial is conducted

Russian Federation, 

Outcome
Type Measure Description Time frame Safety issue
Primary freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia 3 years Yes
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