Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Prospective Randomized Study

NCT ID: NCT02171364

Last Updated: 2019-03-18

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

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-09-01

Brief Summary

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Radiofrequency catheter ablation is highly effective in the treatment of patients with persistent atrial fibrillation. In order to decrease the recurrence rate after catheter ablation, the investigators propose to apply 'virtual' ablation on patient-specific atria by simulating 3D atrial computer model. The investigators will test with five different set of ablation methods and find successful methods for a specific patient. Then, this result will be compared to empirical catheter ablation result by randomly controlled trial.

Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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virtual simulation

This intervention group is to choose the best effective method operation to patients by simulating 3D atrial computer model which consider patient's heart size and shape.

Group Type EXPERIMENTAL

Virtual ablation in based 3D CT of patient who diagnosed AF

Intervention Type PROCEDURE

conventional ablation

The other intervention group is to operate the atrial fibrillation by physician's personal experience, not by virtual simulation.

Group Type ACTIVE_COMPARATOR

conventional ablation based on physician's personal experience

Intervention Type PROCEDURE

Interventions

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Virtual ablation in based 3D CT of patient who diagnosed AF

Intervention Type PROCEDURE

conventional ablation based on physician's personal experience

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of AF patients who performed catheter ablation of atrial fibrillation due to uncontrolled pulse rate by anti-arrhythmic drug therapy.

Exclusion Criteria

* AF patients who have severe heart deformations or blood problems.
* The patients who had been performed catheter ablation of atrial ablation.
* The patients who missed out to recording of 3D CT, echo and electrocardiography.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim IS, Lim B, Shim J, Hwang M, Yu HT, Kim TH, Uhm JS, Kim SH, Joung B, On YK, Oh S, Oh YS, Nam GB, Lee MH, Shim EB, Kim YH, Pak HN; CUVIA-AF1 Investigators. Clinical Usefulness of Computational Modeling-Guided Persistent Atrial Fibrillation Ablation: Updated Outcome of Multicenter Randomized Study. Front Physiol. 2019 Dec 17;10:1512. doi: 10.3389/fphys.2019.01512. eCollection 2019.

Reference Type DERIVED
PMID: 31920716 (View on PubMed)

Other Identifiers

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4-2013-0536

Identifier Type: -

Identifier Source: org_study_id

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