Clinical trial NCT01466842: Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
Official title: Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paroxysmal Atrial Fibrillation
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: 3 years
measure: comparison of the subjective findings of recurrence of AF by the patient through QoL and symptom questionnaires
timeFrame: 3, 6, 12, 24 and 36 months
measure: number of track complications, both acute (during the procedure) and chronic throughout the trial
timeFrame: 3 years
measure: hospitalization rate during a two and a half year follow-up following the initial six months follow-up
timeFrame: 3 years
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
Study officials:
References: