Ablation as First Line Treatment in Paroxysmal Atrial Fibrillation

Maastricht University Medical Center1 site in 1 country160 target enrollmentJanuary 2012

ConditionsParoxysmal Atrial Fibrillation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Paroxysmal Atrial Fibrillation
Sponsor: Maastricht University Medical Center
Enrollment: 160
Locations: 1
Primary Endpoint: 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
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

January 2016

Last Updated

14 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Maastricht University Medical Center

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Secondary Outcomes

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)