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NCT02438176 Clinical Trial

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

Paroxysmal Atrial Fibrillation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02438176
Other study ID # 4-2015-0170
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2, 2015
Est. completion date March 9, 2018

Study information
Verified date February 2019
Source Yonsei University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 105
Est. completion date March 9, 2018
Est. primary completion date March 9, 2018
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• single trans-septal puncture
The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.
• conventional bilateral groin puncture
Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.

Locations
Country Name City State
Korea, Republic of Severance Cardiovascular Hospital, Yonsei University Health System Seoul

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient's subjective discomfort 6month after procedure
Secondary Procedure time 1day
Secondary Procedure related complication rate 1 month after procedure
Secondary Long-term AF recurrence rate 12 month after procedure
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