Comparison of Circumferential Pulmonary Vein Isolation Alone Versus Linear Ablation in Addition to Circumferential Pulmonary Vein Isolation for Catheter Ablation in Persistent Atrial Fibrillation: Prospective Randomized Controlled Trial

January 18, 2019 updated by: Yonsei University
The purpose of this study is to compare the clinical outcomes depending on catheter ablation strategy for persistent atrial fibrillation. After randomization, investigators will conduct circumferential pulmonary vein isolation alone in a group, and additional posterior box isolation and anterior linear ablation in the other group. Investigators will compare clinical recurrence rate, complication rate, and procedure time, etc.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Cardiovascular Hospital, Yonsei University Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with persistent Atrial fibrillation (20~80 years)
  • LA diameter <55mm
  • patients possible to anticoagulation and anti arrhythmic drug

Exclusion Criteria:

  • Structural cardiac disease
  • Contraindication to brain perfusion CT
  • Catheter ablation history for AF,
  • Cardiac surgery for AF
  • active internal bleeding
  • Impossible to anticoagulation or antiarrhythmic drug
  • valvular AF (MA> GII, Mechanical valve, Mitral valve replacement)
  • Patients with severe medical disease
  • Expected survival < 1year
  • Severe alcoholics, drug addiction

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: circumferential pulmonary vein isolation
Procedure: circumferential pulmonary vein isolation
Experimental: Linear ablation in addiction to pulmonary vein isolation
Procedure: Linear ablation in addiction to circumferential pulmonary vein isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence of atrial fibrillation after catheter ablation
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Time Frame
procedure time
Time Frame: 1 day
1 day
procedure related complication rate
Time Frame: 12 month
12 month
rate of hospitalization
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 25, 2016

First Posted (Estimate)

March 28, 2016

Study Record Updates

Last Update Posted (Actual)

January 22, 2019

Last Update Submitted That Met QC Criteria

January 18, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2016-0029

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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