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

Not Applicable

Completed

• Conditions: Paroxysmal Atrial Fibrillation
• Interventions: Procedure: single trans-septal puncture; Procedure: conventional bilateral groin puncture

• Registration Number: NCT02438176
• Lead Sponsor: Yonsei University

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2015-05-03
• Study First Submitted QC: 2015-05-07
• Study First Posted: 2015-05-08
• Study Start: 2015-06-02
• Primary Completion: 2018-03-09
• Study Completion: 2018-03-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single puncture group	single trans-septal puncture	single trans-septal puncture
conventional group	conventional bilateral groin puncture	conventional bilateral groin puncture

Primary Outcome Measures

Name	Time	Method
Patient's subjective discomfort	6month after procedure

Secondary Outcome Measures

Name	Time	Method
Procedure time	1day
Procedure related complication rate	1 month after procedure
Long-term AF recurrence rate	12 month after procedure

Trial Locations

Locations (1)

Severance Cardiovascular Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of