Paroxysmal Atrial Fibrillation
Conditions
Brief summary
The purpose of this study is to determine whether catheter ablation is more effective than antiarrhythmic drugs in the early stages of paroxysmal atrial fibrillation. In all the patients a subcutaneous loop recorder will be implanted.
Interventions
PROCEDURECatheter 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.
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 * 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
* Paroxysmal AF for more than three years * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy during a follow-up period of 6 months | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| any recurrence of symptomatic AF or asymptomatic AF and atrial flutter/tachycardia in the absence of AAD therapy after the initial six months follow-up | 3 years |
| comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires | 3, 6, 12, 24 and 36 months |
| number of track complications, both acute (during the procedure) and chronic throughout the trial | 3 years |
| hospitalization rate during a two and a half year follow-up following the initial six months follow-up | 3 years |
Countries
Netherlands
Contacts
Primary ContactLaurent Pison, MD
Outcome results
None listed