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Ablation or Surgery for Atrial Fibrillation (AF) Treatment

NCT00662701 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-11-20

No results posted yet for this study

Summary

The purpose of this study is to compare 2 invasive strategies for Atrial Fibrillation treatment, Endocardial catheter ablation isolation of the Pulmonary veins versus minimally invasive thoracoscopic surgical epicardial isolation. Both strategies are in use for several years now, and have been reported as a successful strategy with success rates of 60-90%. However, it is not known which technique is preferable in a given patient population in terms of efficacy to cure AF, safety, or patient discomfort. Therefore, in the present trial a randomized study is proposed to provide more insight into the relative merits of both techniques

Conditions

Interventions

PROCEDURE

Catheter Ablation

RF ablation with complete circumferential ablation around the right and PVs, optional additional lines between the lower and upper PVs, and towards the mitral valve ring.

PROCEDURE

Surgical Ablation

Minimal invasive thoracoscopic surgery including isolation of the PVs by AtriCure and removal of the LAA.

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • AtriCure, Inc.

    collaborator INDUSTRY

  • St. Antonius Hospital

    lead OTHER

Principal Investigators

  • Lucas Boersma, MD/PhD · St. Antonius Hospital

  • WimJan van Boven, MD · St. Antonius Hospital

  • Lluis Mont, MD · Hospital Clinic of Barcelona

  • Castella M, MD · Hospital Clinic of Barcelona

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2012-11-30
Completion
2013-01-31

Countries

  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT00662701 on ClinicalTrials.gov