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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:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00296166
First received: February 23, 2006
Last updated: September 1, 2010
Last verified: July 2007
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296166

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

No publications provided

ClinicalTrials.gov Identifier: NCT00296166     History of Changes
Other Study ID Numbers: KAT-SKOPI study, KF - 01-284215
Study First Received: February 23, 2006
Last Updated: September 1, 2010
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on June 13, 2013