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OpenTrials
Completed

NCT Number: NCT01703247

Ganglionated Plexi Ablation Combined With Pulmonary Vein Isolation

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).

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

State Research Institute of CIrculation Pathology

Novosibirsk, 630055, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persistent and longstanding persistent AF

Exclusion criteria

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

Treatment and study plan

pulmonary vein isolation

Procedure

Ganglionated plexi ablation

Procedure

Linear Lesion Ablation

Procedure

Primary outcomes

  1. freedom of atrial tachyarrhythmia, including AF and atrial flutter/tachycardia

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Meshalkin Research Institute of Pathology of Circulation

Network

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 10, 2012
Registry last updated
Oct 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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