Zero-fluoroscopic Cryoballoon Ablation

NCT ID: NCT05711589

Last Updated: 2023-02-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-12-31

Brief Summary

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This study aimed to investigate safety and efficacy of intracardiac echocardiography (ICE)-guided zero-fluoroscopic cryoballoon ablation (CBA) in patients with paroxysmal atrial fibrillation.

Detailed Description

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Patients (n=100) undergoing de novo CBA for paroxysmal AF were randomly assigned (1:1) to zero-fluoroscopic (Zero-X) and conventional fluoroscopy groups.

Radiation exposure, procedural time, acute and long term outcome were analyzed.

Conditions

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Atrial Fibrillation Paroxysmal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

zero-fluoroscopic and conventional fluoroscopy groups
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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conventional group

cryoablation (CBA) was performed under fluoroscopic guidance

Group Type PLACEBO_COMPARATOR

cryoablation (CBA) was performed under fluoroscopic guidance

Intervention Type PROCEDURE

cryoablation (CBA) was performed under fluoroscopic guidance

Zero-X group

CBA was performed under intracardiac echocardiography guidance without fluoroscopy

Group Type EXPERIMENTAL

CBA was performed under intracardiac echocardiography guidance without fluoroscopy

Intervention Type PROCEDURE

Zero-X group: Patients undergoing ICE-guided CBA

Interventions

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CBA was performed under intracardiac echocardiography guidance without fluoroscopy

Zero-X group: Patients undergoing ICE-guided CBA

Intervention Type PROCEDURE

cryoablation (CBA) was performed under fluoroscopic guidance

cryoablation (CBA) was performed under fluoroscopic guidance

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing de novo CBA for symptomatic paroxysmal atrial fibrillation

Exclusion Criteria

* age \< 18 years
* history of AF ablation or cardiac surgery
* contraindication to oral anticoagulants
* presence of intracardiac thrombus or significant coronary artery disease on cardiac computed tomography prior to the procedure.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pusan National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hong Euy Lim, MD

Role: STUDY_CHAIR

Hallym University Medical Center

Locations

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Hallym University Sacred Heart Hospital

Anyang, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HALLYM 2019-04-025-001

Identifier Type: -

Identifier Source: org_study_id

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