Clinical trial NCT02814136: Wide Area Circular Ablation Versus Extra-wide Area Circular Ablation in Persistent Atrial Fibrillation
Official title: Comparison of Wide Area Circular Ablation With Extra-wide Area Circular Ablation in Subjects With Persistent Atrial Fibrillation, a Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Mosaic Life Care
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ablation of atrial fibrillation is an established method for treatment of subjects with atrial fibrillation with goal of restoration of sinus rhythm. Among different methods, wide area circular ablation (WACA) is shown to provide the same results with fewer complications. This project will compare WACA with extra-wide area circular ablation (E-WACA) in subjects who are considered for ablation of atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* All subjects with symptomatic persistent atrial fibrillation who are scheduled for clinically indicated ablation of AF.

Exclusion Criteria:

* Subjects younger than 18 year of age.
* Subjects who are pregnant.
* Subjects who are unable to provide consent.

Primary outcomes:
measure: To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.
timeFrame: 1 year
Secondary outcomes:
measure: ii. To compare the time to reoccurrence of atrial fibrillation, atrial flutter and/or atrial tachycardia in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.
timeFrame: 1 year
Other outcomes:
measure: iii. To assess the frequency of complications in subjects undergoing ablation of atrial fibrillation using WACA compare to E-WACA.
timeFrame: 1 year
Locations:
city: Saint Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
Study officials:
affiliation: Physician of Cardiology and Electrophysiology
name: Mazda Biria, MD
role: PRINCIPAL_INVESTIGATOR
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