Ablation as first line treatment of paroxysmal atrial fibrillatio

Completed

• Conditions: atrial fibrillation; paroxysmal atrial fibrillation; 10007521

• Registration Number: NL-OMON39542
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Trial ended prematurely

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-07-01
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 5

Inclusion Criteria

Patients will be eligible for inclusion in the study if they meet all of the following 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

Subjects are excluded from the study if any of the following conditions are present (for all procedures):
* 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:
o Cardiac surgery within six months of screening
o 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
o Unstable angina
o Myocardial infarction within six months of screening
o Surgically corrected atrial septal defect with a patch or closure device
o 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint of this study is any recurrence of symptomatic AF or<br /><br>asymptomatic AF and atrial flutter/tachycardia during a follow-up period of 6<br /><br>months after the blanking period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) any recurrence of symptomatic AF or asymptomatic AF and atrial<br /><br>flutter/tachycardia in the absence of AAD therapy after the initial six months<br /><br>follow-up, 2) comparison of the subjective findings of recurrence of AF by the<br /><br>patient through QoL and symptom questionnaires, 3) number of track<br /><br>complications, both acute (during the procedure) and chronic throughout the<br /><br>trial and 4) hospitalization rate during a two and a half year follow-up<br /><br>following the initial six months follow-up.</p><br>