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Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation

This study has been terminated.
(Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296166
First Posted: February 24, 2006
Last Update Posted: September 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Rigshospitalet, Denmark
  Purpose

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.


Condition Intervention
Atrial Fibrillation Procedure: Catheter ablation Procedure: Thoracoscopic epicardial ablation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Presence of sinus rhythm [ Time Frame: after 6 months from treatment ]

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

Estimated Enrollment: 200
Study Start Date: November 2006
Estimated Study Completion Date: November 2010
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296166


Locations
Denmark
Risghospitalet,
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Jesper H Svendsen, MD Rigshospitalet, Denmark
  More Information

ClinicalTrials.gov Identifier: NCT00296166     History of Changes
Other Study ID Numbers: KAT-SKOPI study
KF - 01-284215
First Submitted: February 23, 2006
First Posted: February 24, 2006
Last Update Posted: September 2, 2010
Last Verified: July 2007

Keywords provided by Rigshospitalet, Denmark:
Atrial fibrillation
Permanent Atrial fibrillation
catheter ablation
thoracoscopy
Arrhythmia
Heart

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes