Study Stopped
Patients with permanent AF are seldomly symptomatic enough to justify intervention. We decided to stop inclusion due to low recruitment rate.
Catheter Ablation Versus Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation
A Randomized Study That Will Show the Effects of Catheter Ablation Compared to the Effects of Thoracoscopic Ablation to Patients With Permanent Atrial Fibrillation.
2 other identifiers
interventional
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Nov 2006
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2010
CompletedSeptember 2, 2010
July 1, 2007
February 23, 2006
September 1, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of sinus rhythm
after 6 months from treatment
Secondary Outcomes (8)
complications
during 12 months from treatment
cost-effectiveness
during 12 months from treatment
structural changes (evaluated by echocardiography)
during 12 months from treatment
p-BNP
during 12 months from treatment
inflammatory markers
during 12 months from treatment
- +3 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Risghospitalet,
Copenhagen, 2100, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jesper H Svendsen, MD
Rigshospitalet, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 23, 2006
First Posted
February 24, 2006
Study Start
November 1, 2006
Study Completion
November 1, 2010
Last Updated
September 2, 2010
Record last verified: 2007-07