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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02438176
Enrollment
105
Registered
2015-05-08
Start date
2015-06-02
Completion date
2018-03-09
Last updated
2019-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal Atrial Fibrillation

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.

Interventions

PROCEDUREsingle trans-septal puncture

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

PROCEDUREconventional bilateral groin puncture

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Patient's subjective discomfort6month after procedure

Secondary

MeasureTime frame
Procedure time1day
Procedure related complication rate1 month after procedure
Long-term AF recurrence rate12 month after procedure

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026