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

NCT ID: NCT02031705

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2019-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Paroxysmal Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cavotricuspid isthmus ablation

Isthmus ablation was performed in paroxysmal atrial fibrillation patients.

Group Type ACTIVE_COMPARATOR

cavotricuspid isthmus ablation

Intervention Type PROCEDURE

Isthmus ablation was performed in paroxysmal atrial fibrillation patients.

control group

Control group was performed no additional cavotricuspid isthmus ablation.

Group Type PLACEBO_COMPARATOR

control group

Intervention Type PROCEDURE

Control group was performed no additional cavotricuspid isthmus ablation.

Interventions

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cavotricuspid isthmus ablation

Isthmus ablation was performed in paroxysmal atrial fibrillation patients.

Intervention Type PROCEDURE

control group

Control group was performed no additional cavotricuspid isthmus ablation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Scheduled ablation for paroxysmal atrial fibrillation

Exclusion Criteria

* Typical atrial flutter
* History of artificial tricuspid valve surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yong Seog Oh

OTHER

Sponsor Role lead

Responsible Party

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Yong Seog Oh

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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SungHwan Kim, MD

Role: STUDY_DIRECTOR

Seoul St. Mary's Hospital

Locations

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Seoul st. mary's hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim SH, Oh YS, Choi Y, Hwang Y, Kim JY, Kim TS, Kim JH, Jang SW, Lee MY, Joung B, Choi KJ. Long-Term Efficacy of Prophylactic Cavotricuspid Isthmus Ablation during Atrial Fibrillation Ablation in Patients Without Typical Atrial Flutter: a Prospective, Multicentre, Randomized Trial. Korean Circ J. 2021 Jan;51(1):58-64. doi: 10.4070/kcj.2020.0174. Epub 2020 Sep 14.

Reference Type DERIVED
PMID: 33150753 (View on PubMed)

Other Identifiers

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CTI

Identifier Type: -

Identifier Source: org_study_id

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