Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation: Virtual Rotor Mapping and Catheter Ablation

NCT ID: NCT02558699

Last Updated: 2023-01-03

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

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-24

Study Completion Date

2027-12-31

Brief Summary

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Radiofrequency catheter ablation is effective in the treatment of patients with paroxysmal atrial fibrillation. In order to reduce 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 conduct virtual rotor mapping in the patient specific atrial model. Then, the investigators will compare the clinical outcome of conventional circumferential pulmonary vein isolation and additional rotor ablation guided by virtual rotor mapping.

Detailed Description

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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

Investigators

Study Groups

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conventional group

Group operating the atrial fibrillation by physician's personal experience, not by virtual simulation.

Group Type ACTIVE_COMPARATOR

physician's personal experience

Intervention Type PROCEDURE

physician's personal experience

3D atrial computer model

Group choosing choose the best effective rotor mapping by simulating 3D atrial computer model which consider patinet's heart size and shape.

Group Type EXPERIMENTAL

Virtual rotor mapping

Intervention Type PROCEDURE

Virtual rotor mapping

Interventions

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physician's personal experience

physician's personal experience

Intervention Type PROCEDURE

Virtual rotor mapping

Virtual rotor mapping

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* AF patient age 19\~80
* 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 vascular disease.
* The patient who have renal disease of eGFR\<30mL/min
* The patients who had been performed catheter ablation of atrial ablation and MAZE.
* The patients who missed out to recording of 3D CT, echo and electrocardiography.
* the patient have experienced major hemorrhagic complication
* The patient have experienced ischemic cerebral infarction more 2 times
* The patient who have risk of ischemic cerebral infarction (CHA2DS2-VASc Score \>5)
Minimum Eligible Age

19 Years

Maximum Eligible Age

80 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 Cardiovascular Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Hui-Nam Pak

Role: CONTACT

82-2-2228-8459

Facility Contacts

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Hui-Nam Pak, M.D., Ph.D.

Role: primary

82-2-2228-8459

References

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Choi Y, Lim B, Yang SY, Yang SH, Kwon OS, Kim D, Kim YG, Park JW, Yu HT, Kim TH, Yang PS, Uhm JS, Shim J, Kim SH, Sung JH, Choi JI, Joung B, Lee MH, Kim YH, Oh YS, Pak HN; CUVIA-REGAB Investigators. Clinical Usefulness of Virtual Ablation Guided Catheter Ablation of Atrial Fibrillation Targeting Restitution Parameter-Guided Catheter Ablation: CUVIA-REGAB Prospective Randomized Study. Korean Circ J. 2022 Sep;52(9):699-711. doi: 10.4070/kcj.2022.0113. Epub 2022 Jul 11.

Reference Type DERIVED
PMID: 35927040 (View on PubMed)

Other Identifiers

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4-2015-0646

Identifier Type: -

Identifier Source: org_study_id

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