Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation - Full Text View

Sponsored by:	Rigshospitalet, Denmark
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00296166

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

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Arrhythmia Atrial Fibrillation

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
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.

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

Contacts

Contact: Jesper H Svendsen, MD	(45) 35452817	hastrup@rh.dk
Contact: Daniel Steinbrückel, MD	(45) 35458016

Locations

Denmark
Risghospitalet,	Recruiting
Copenhagen, Denmark, 2100
Contact: Xu Chen 3545 2817
Contact: Jens Lund, MD 3545 1099
Sub-Investigator: Steen Pehrson, MD
Sub-Investigator: Helen H Petersen, MD
Sub-Investigator: Xu Chen, MD
Sub-Investigator: Jens Lund, `MD

Sponsors and Collaborators

Rigshospitalet, Denmark

Investigators

Principal Investigator:

Jesper H Svendsen, MD

Rigshospitalet, Denmark

More Information

No publications provided

Study ID Numbers:	KAT-SKOPI study, KF - 01-284215
Study First Received:	February 23, 2006
Last Updated:	September 4, 2007
ClinicalTrials.gov Identifier:	NCT00296166 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by Rigshospitalet, Denmark:

Atrial fibrillation
Permanent Atrial fibrillation
catheter ablation

thoracoscopy
Arrhythmia
Heart

Study placed in the following topic categories:

Heart Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 06, 2009