- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448656
Treatment of Atrial Fibrillation by Minimal Invasive Surgery (ABOLISH-AF)
June 18, 2012 updated by: I.C. Van Gelder, University Medical Center Groningen
Treatment of Atrial Fibrillation by Minimal Invasive Epicardial Pulmonary Vein Isolation: The ABOLISH-AF Study
The purpose of this study is to determine the feasability of a new epicardial and minimal invasive ablation technique of the left atrium isolating the pulmonary veins for prevention of atrial fibrillation recurrences in patients with antiarrhythmic drug refractory lone atrial fibrillation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Atrial fibrillation is a major health problem.Despite adequate treatment of underlying heart disease, rhythm control is unsuccessful in almost half of patients, also in patients with lone atrial fibrillation.If patients remain highly symptomatic, a non-pharmacological approach may be considered including pulmonary vein isolation and Cox maze III surgery.
Maze III surgery has high succes rates, however it includes major cardiac surgery with substantial risk of complications.
New surgical strategies for symptomatic lone atrial fibrillation focus on minimal invasive off-pump procedures omitting cardiopulmonary bypass (and thus lowering the complication rate), while taking advantage of an easier approach to the ablation site and a shorter procedure time.
Epicardial surgical ablation isolating pulmonary veins by high intensity focused ultrasound performed off-pump by Video Assisted Thoracic Surgery (VATS)may be a promising treatment option.
In this pilot study, we aim to study the feasibility of this new surgical ablation approach in patients with lone atrial fibrillation.
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 2
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
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-
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Groningen, Netherlands, 9700 RB
- University Medical Center Groningen
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-
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 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Documented symptomatic lone paroxysmal or persistent atrial fibrillation, which either convert spontaneously or can be terminated with antiarrhythmic drugs or by an electrical cardioversion.
- The patient had a least one episode of persistent atrial fibrillation or three episodes of paroxysmal atrial fibrillation during the last three months.
- Duration present episode persistent atrial fibrillation less then one year.
- The patient has been treated with at least two different antiarrhythmic drugs (class I-IV) of which at least one belongs to class I or III.
- The patient will sign and date the written informed consent prior to study participation.
Exclusion Criteria:
- Age <18 and >76 years.
- Contraindications for oral anticoagulation.
- Signs of sick sinus syndrome or AV conduction disturbances (i.e. symptomatic bradycardia or asystole > 3 seconds or escape rate < 40 beats per minute in awake symptom-free patients).
- Permanent atrial fibrillation defined as atrial fibrillation continuously present and not convertible to sinus rhythm by an electrical cardioversion or antiarrhythmic drugs.
- Previous transvenous pulmonary vein isolation, Maze surgery, or other cardiac surgery.
- Heart failure defined as NYHA class III-IV heart failure.
- Previously implanted intracardiac device or has current or foreseen pacemaker, internal cardioverter defibrillator (ICD) and/ or cardiac resynchronization therapy.
- Clinically relevant valvular heart disease.
- Coronary artery disease or an old myocardial infarction
- Acute or chronic infection.
- Untreated clinical hypo- or hyperthyroidism or < 3 months euthyroidism.
- Uncontrolled hypertension, defined as a systolic blood pressure > 160 mm Hg and/or a diastolic blood pressure > 95 mm Hg (anti-hypertensive treatment is allowed).
- The patient has a concurrent medical condition (i.e. alcohol or drug abuse or a severe progressive extracardiac disease) or is unlikely to comply with the protocol.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
sinus rhythm at end of follow-up (6 months)
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mortality
Time Frame: 6 months
|
6 months
|
absence of permanent atrial fibrillation at end of follow-up
Time Frame: 6 months
|
6 months
|
absence of any symptomatic atrial fibrillation
Time Frame: 6 months
|
6 months
|
atrial volume and contraction at end of follow-up
Time Frame: 6 months
|
6 months
|
left ventricular diameters and function at end of follow-up
Time Frame: 6 months
|
6 months
|
thromboembolism
Time Frame: 6 months
|
6 months
|
pulmonary vein stenosis
Time Frame: 6 months
|
6 months
|
immediate postoperative complications (and related sequelae)
Time Frame: directly post-operative
|
directly post-operative
|
surgical procedure time and total epicardial ablation time
Time Frame: directly post-operative
|
directly post-operative
|
any pacemaker implantation
Time Frame: 6 months
|
6 months
|
bleeding
Time Frame: 6 months
|
6 months
|
hospitalization for heart failure
Time Frame: 6 months
|
6 months
|
antiarrhythmic drugs during follow-up
Time Frame: 6 months
|
6 months
|
electrical cardioversions during follow-up
Time Frame: 6 months
|
6 months
|
re-ablations
Time Frame: 6 months
|
6 months
|
syncope
Time Frame: 6 months
|
6 months
|
quality of life and specific arrhythmia symptoms
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Isabelle C. Vam Gelder, MD, University Medical Center Groningen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
June 1, 2006
Primary Completion (Actual)
December 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
March 15, 2007
First Submitted That Met QC Criteria
March 15, 2007
First Posted (Estimate)
March 19, 2007
Study Record Updates
Last Update Posted (Estimate)
June 19, 2012
Last Update Submitted That Met QC Criteria
June 18, 2012
Last Verified
June 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p06.0550l
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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