Circumferential Versus Ganglionated Plexi Ablation for Atrial Fibrillation (AF)

NCT00671905 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-04-11

No results posted yet for this study

Summary

The investigators have recently shown that anatomic ganglionated plexi (GP) ablation is inferior to circumferential pulmonary vein (PV) ablation for the treatment of paroxysmal AF. In this study, however, 26% of patients subjected to GP ablation alone without circumferential lesions were free of AF-recurrence up to one year after the ablation procedure. The investigators hypothesized that a combination of circumferential ablation with high-frequency-stimulation-identified GP ablation is superior to conventional circumferential ablation for the prevention of recurrences of paroxysmal atrial fibrillation (AF). The investigators are, therefore, conducting a randomized study comparing conventional circumferential ablation to a combination of circumferential ablation plus specific right and left atrial GP ablation in patients with drug-refractory paroxysmal AF.

Conditions

Interventions

PROCEDURE

GP ablation

HF stimulation-guided and anatomic ablation of the main right and left atrial GP

PROCEDURE

PV isolation

Circumferential PV isolation

Sponsors & Collaborators

  • Cardiovascular Research Society, Greece

    lead OTHER

Principal Investigators

  • D Katritsis, MD · Cardiovascular Research Society

  • E Pokushalov, MD · State Research Institute of Circulation Pathology, Novosibirsk, Russia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2011-05-31
Completion
2011-08-31

Countries

  • Greece
  • Russia

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00671905 on ClinicalTrials.gov