Status:
COMPLETED
Treatment of Atrial Fibrillation by Minimal Invasive Surgery
Lead Sponsor:
University Medical Center Groningen
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-76 years
Phase:
PHASE2
Brief Summary
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 fibrilla...
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 fibri...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00448656
Start Date
June 1 2006
End Date
December 1 2008
Last Update
June 19 2012
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9700 RB