Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
NCT ID: NCT01466842
Last Updated: 2011-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2012-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Catheter ablation
Catheter ablation using cryothermia
Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.
Antiarrhythmic drugs
Three months before starting antiarrhythmic drugs, a subcutaneous loop recorder will be implanted.
No interventions assigned to this group
Interventions
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Catheter ablation using cryothermia
Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.
Eligibility Criteria
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Inclusion Criteria
* At least three episodes of paroxysmal atrial fibrillation documented on an electrocardiogram or event recording during the last three years
* Never taken antiarrhythmic drugs or at most a pill in the pocket approach
* Willingness, ability and commitment to participate in baseline and follow-up evaluations
Exclusion Criteria
* An episode of atrial fibrillation that lasted more than seven days within the past six months
* Persistent/permanent atrial fibrillation
* Atrial fibrillation from reversible cause (i.e. surgery, hyperthyroidism, pericarditis)
* Documented atrial flutter
* Structural heart disease of clinical significance including:
* Cardiac surgery within six months of screening
* Unstable symptoms of congestive heart failure (CHF) including NYHA Class III or IV CHF at screening and/or ejection fraction \<30% as measured by echocardiography or catheterization
* Unstable angina
* Myocardial infarction within six months of screening
* Surgically corrected atrial septal defect with a patch or closure device
* LA size \> 40mm
* Any prior ablation of the pulmonary veins
* Enrollment in any other ongoing protocol
* Untreatable allergy to contrast media
* Pregnancy
* Any contraindication to cardiac catheterization
* Prosthetic mitral heart valve
* Poor general health that, in the opinion of the Investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, etc.)
* Contraindication to coumadin or heparin
* History of pulmonary embolus or stroke within one year of screening
* Acute pulmonary edema
* Atrial clot on TEE regardless of the patient's anticoagulation medication status
18 Years
65 Years
ALL
No
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Maastricht University Medical Centre
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AFLIT-PAF 1.2
Identifier Type: -
Identifier Source: org_study_id