Comparison of Single Groin and Single Trans-septal Puncture and Conventional Bilateral Groin Puncture and Double Trans-septal Puncture in Catheter Ablation for Atrial Fibrillation

NCT ID: NCT02438176

Last Updated: 2019-02-26

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-02

Study Completion Date

2018-03-09

Brief Summary

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The purpose of this study is to compare single groin puncture and bilateral groin puncture during AF ablation procedure. The investigators will compare 1) the degree of patients' discomfort during hemostasis by questionaire, 2) procedure time, 3) complication rates, and 4) 1-year clinical recurrence rate of AF.

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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single puncture group

single trans-septal puncture

Group Type EXPERIMENTAL

single trans-septal puncture

Intervention Type PROCEDURE

The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.

conventional group

conventional bilateral groin puncture

Group Type ACTIVE_COMPARATOR

conventional bilateral groin puncture

Intervention Type PROCEDURE

Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.

Interventions

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single trans-septal puncture

The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.

Intervention Type PROCEDURE

conventional bilateral groin puncture

Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients agreement of consent
2. Patients who age more than 19
3. patients who undergoing catheter ablation of atrial fibrillation
4. Patients who are not vascular disease

Exclusion Criteria

1. patients who do not agree with study inclusion
2. persistent AF
3. Patients with vascular disease or venous anomaly
4. Patients with structural abnormality of the heart
Minimum Eligible Age

19 Years

Maximum Eligible Age

75 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

Countries

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South Korea

Other Identifiers

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4-2015-0170

Identifier Type: -

Identifier Source: org_study_id

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