Recruiting

Wide Area Ablation

Sponsor:

Mosaic Life Care

Code:

NCT02814136

Conditions

Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ablation

Study Details

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.

Conditions

Atrial Fibrillation

Study ID

NCT02814136

Start date

Jul, 2016

Status verified date

Aug, 2019

Completion date

Jul, 2021

Anticipated

Primary completion date

Jul, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

146 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: WACA

wide area circular ablation

active comparator: EWACA

extra-wide area circular ablation

Interventions

Ablation

Primary outcome measure

  • To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA. [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Mosaic Life Care

Recruiting

Saint Joseph, Missouri, United States, 64506

Contacts

Principal Investigator:

Mazda Biria, MD

More Information

Sponsor

Mosaic Life Care

Last update posted

Aug 30, 2019

Last verified

Aug, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Mosaic Life Care on 2019-08-30.