Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

September 1, 2010 updated by: Rigshospitalet, Denmark

A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.

Patents with atrial fibrillation can be treated with the purpose of curing the arrhythmia.This may be achieved by catheter ablation and Maze surgery where the latter includes open heart surgery.

By catheter ablation the arrhythmia can be cured in about 70 % of patients who have episodes of atrial fibrillation. In patients with permanent atrial fibrillation the results are not as good.

We will compare a conventional ablation approach where lesions are created on the inside of the heart with a thoracoscopic approach where the lesions are created from the outside of the heart.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients with permanent atrial fibrillation will be considered for randomisation Patients will be randomised to either conventional endocardial catheter ablation or epicardial thoracoscopic ablation.

Objectives of study:

Primary endpoint:presence of sinus rhythm after 6 months Secondary endpoints: complications, cost-effectiveness, structural changes (evaluated by echocardiography), p-BNP and inflammatory markers, atrial fibrillation burden evaluated by Holter monitoring

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Risghospitalet,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Permanent atrial fibrillation documented on at least 2 ecg´s with more than 1 month between ecg´s. The diagnosis is verified on Holter.
  • All patients have symptoms or do not tolerate rate control treatment.

Exclusion Criteria:

  • Psychiatric disease or suspicion of incapability to give informed concent
  • Females with birth giving potential
  • Previous heart surgery
  • Previous ablation for atrial fibrillation
  • Life expectance less than 1 year
  • Congenital heart disease
  • Expected need for heart surgery
  • Heart failure (NYHA class IV)
  • Inability to be treated with anticoagulation
  • In case of previous deep venous thromboembolism og stroke the investigators will individually consider if the patient is suitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of sinus rhythm
Time Frame: after 6 months from treatment
after 6 months from treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
complications
Time Frame: during 12 months from treatment
during 12 months from treatment
cost-effectiveness
Time Frame: during 12 months from treatment
during 12 months from treatment
structural changes (evaluated by echocardiography)
Time Frame: during 12 months from treatment
during 12 months from treatment
p-BNP
Time Frame: during 12 months from treatment
during 12 months from treatment
inflammatory markers
Time Frame: during 12 months from treatment
during 12 months from treatment
atrial fibrillation burden evaluated by Holter monitoring
Time Frame: at 6 months from treatment
at 6 months from treatment
exercise performance
Time Frame: at 3 months from treatment
at 3 months from treatment
Quality of life
Time Frame: at 3 months from treatment
at 3 months from treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Investigators

  • Principal Investigator: Jesper H Svendsen, MD, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

February 23, 2006

First Submitted That Met QC Criteria

February 23, 2006

First Posted (Estimate)

February 24, 2006

Study Record Updates

Last Update Posted (Estimate)

September 2, 2010

Last Update Submitted That Met QC Criteria

September 1, 2010

Last Verified

July 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KAT-SKOPI study
  • KF - 01-284215

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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