Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus Block in Patients With Paroxysmal Atrial Fibrillation

March 26, 2019 updated by: Yonsei University
Prospective Randomized Study on Clinical Effectiveness of Carvo-Tricuspid Isthmus (CTI) Block in Patients with Paroxysmal Atrial Fibrillation (PAF) will be performed. Study will be composed with two arms including 4 pulmonary vein isolation and pulmonary vein isolation with CTI block. After that all patients will be followed up by HRS(Heart Rhythm Society) 2010 expert consensus guideline.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

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
        • ivision of Cardiology, Yonsei University Health System, Yonsei University College of Medicine

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients with documented AF
  • Drug refractory AF
  • Non-valvular AF
  • No structural cardiac disease
  • No intracardiac thrombi in cardiac CT and TEE

Exclusion Criteria:

  • permanent AF refractory to electrical cardioversion
  • LA size >55 mm as measured by echocardiography
  • AF with valvular disease
  • associated structural heart disease other than left ventricular hypertrophy
  • prior AF ablation.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CTI group
CTI(Cavo-Tricuspid Isthmus)
Procedure: PVI, CTI block
  • PVI (pulmonary isolation)
  • Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial fibrillation

Catheter is inserted into inferior venacava (IVC) and right atrium (RA) via femoral vein. And the procedure is to block bidirectionally between inferior venacava (IVC) and the annulus of tricuspid valve (TV) by using electrical energy of catheter tip.

Other Names:
  • radiofrequency catheter ablation (RFCA), Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial flutter
Placebo Comparator: Non CTI group
Non CTI (Cavo-Tricuspid Isthmus)
Procedure: PVI
PVI (pulmonary isolation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Atrial fibrillation (AF free survival)
Time Frame: 3 month after catheter ablation
clinical recurrence of AF after catheter ablation
3 month after catheter ablation

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

January 1, 2015

Primary Completion (Actual)

April 26, 2018

Study Completion (Actual)

April 26, 2018

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 17, 2013

First Posted (Estimate)

December 24, 2013

Study Record Updates

Last Update Posted (Actual)

March 27, 2019

Last Update Submitted That Met QC Criteria

March 26, 2019

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2013-0639

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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