Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation

April 21, 2024 updated by: Yong Seog Oh

Effect of Cavotricuspid Isthmus Ablation in Patients Without History of Typical Flutter During Ablation for Paroxysmal Atrial Fibrillation

It has been demonstrated that successful cavotricuspid isthmus ablation may be effective in preventing paroxysmal atrial fibrillation. However, the effectiveness of only isthmus ablation on atrial fibrillation itself is unclear.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Researchers hypothesized that an organized activation pattern around the tricuspid annulus during atrial fibrillation indicated a mother reentrant circuit that could be terminated by a cavocaval isthmus ablation, thus preventing atrial fibrillation. The objectives of the present study were to evaluate the effectiveness of isthmus ablation in preventing atrial fibrillation and to identify predictors of its success.

Study Type

Interventional

Enrollment (Actual)

366

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Scheduled ablation for paroxysmal atrial fibrillation

Exclusion Criteria:

  • Typical atrial flutter
  • History of artificial tricuspid valve surgery

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
Active Comparator: cavotricuspid isthmus ablation
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
Procedure: cavotricuspid isthmus ablation
Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
Placebo Comparator: control group
Control group was performed no additional cavotricuspid isthmus ablation.
Procedure: control group
Control group was performed no additional cavotricuspid isthmus ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom of AF and Af
Time Frame: 1 year after catheter ablation
1 month, 3 months and 12months after ablation follow up visit and Check the recurrence of atrial fibrillation through EKG,Holter, event recording
1 year after catheter ablation

Collaborators and Investigators

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

Sponsor

Yong Seog Oh

Investigators

  • Study Director: SungHwan Kim, MD, Seoul St. Mary's Hospital

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

July 1, 2012

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

August 1, 2019

Study Registration Dates

First Submitted

September 9, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimated)

January 9, 2014

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTI (Other Grant/Funding Number: Swiss Commission Technology and Innovation 12636.1)

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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