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Wide Area Circular Ablation Versus Extra-wide Area Circular Ablation in Persistent Atrial Fibrillation (WACAvsEWACA)

Primary Purpose

Atrial Fibrillation

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ablation
Sponsored by
Mosaic Life Care
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mosaic Life CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

WACA

EWACA

Arm Description

wide area circular ablation

extra-wide area circular ablation

Outcomes

Primary Outcome Measures

To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.

Secondary Outcome Measures

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.

Full Information

First Posted
June 22, 2016
Last Updated
August 29, 2019
Sponsor
Mosaic Life Care
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1. Study Identification

Unique Protocol Identification Number
NCT02814136
Brief Title
Wide Area Circular Ablation Versus Extra-wide Area Circular Ablation in Persistent Atrial Fibrillation
Acronym
WACAvsEWACA
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mosaic Life Care

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
WACA
Arm Type
Active Comparator
Arm Description
wide area circular ablation
Arm Title
EWACA
Arm Type
Active Comparator
Arm Description
extra-wide area circular ablation
Intervention Type
Procedure
Intervention Name(s)
Ablation
Primary Outcome Measure Information:
Title
To evaluate the achievement of sinus rhythm in subjects undergoing ablation of atrial fibrillation using WACA compared to E-WACA.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
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.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
iii. To assess the frequency of complications in subjects undergoing ablation of atrial fibrillation using WACA compare to E-WACA.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Trisha D England, MSN
Phone
816-271-7937
Email
trisha.england2@mymlc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Paula S Wilson, MSN
Phone
816-271-6718
Email
paula.wilson@mymlc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mazda Biria, MD
Organizational Affiliation
Physician of Cardiology and Electrophysiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mosaic Life Care
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trisha D England, MSN
Phone
816-271-7937
Email
trisha.england2@mymlc.com
First Name & Middle Initial & Last Name & Degree
Paula S Wilson, MSN
Phone
816-271-6718
Email
paula.wilson@mymlc.com
First Name & Middle Initial & Last Name & Degree
Mazda Biria, MD

12. IPD Sharing Statement

Plan to Share IPD
No
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Wide Area Circular Ablation Versus Extra-wide Area Circular Ablation in Persistent Atrial Fibrillation

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