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Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01703247
Enrollment
264
Registered
2012-10-10
Start date
2008-01-31
Completion date
2009-05-31
Last updated
2012-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Atrial Fibrillation

Keywords

Arrhythmias, Ablation

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).

Interventions

PROCEDUREPulmonary vein isolation

Sponsors

Meshalkin Research Institute of Pathology of Circulation
Lead SponsorNETWORK

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Persistent and longstanding persistent AF

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia3 years

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026