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
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).
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Russian Federation | State Research Institute of CIrculation Pathology | Novosibirsk |
Lead Sponsor | Collaborator |
---|---|
Meshalkin Research Institute of Pathology of Circulation |
Russian Federation,
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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