Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02721121
Recruitment Status : Recruiting
First Posted : March 28, 2016
Last Update Posted : January 22, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Procedure: circumferential pulmonary vein isolation Procedure: Linear ablation in addiction to circumferential pulmonary vein isolation Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : March 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Recurrence of atrial fibrillation after catheter ablation [ Time Frame: 12 month ]

Secondary Outcome Measures :
  1. procedure time [ Time Frame: 1 day ]
  2. procedure related complication rate [ Time Frame: 12 month ]
  3. rate of hospitalization [ Time Frame: 12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02721121


Locations
Layout table for location information
Korea, Republic of
Severance Cardiovascular Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Hui-Nam Pak, M.D., Ph.D.    82-2-2228-8459    hnpak@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT02721121    
Other Study ID Numbers: 4-2016-0029
First Posted: March 28, 2016    Key Record Dates
Last Update Posted: January 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes