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OpenTrials
Completed

NCT Number: NCT02438176

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

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.

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Key information

Conditions

Paroxysmal Atrial Fibrillation Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients agreement of consent
  • Patients who age more than 19
  • patients who undergoing catheter ablation of atrial fibrillation
  • Patients who are not vascular disease

Exclusion criteria

  • patients who do not agree with study inclusion
  • persistent AF
  • Patients with vascular disease or venous anomaly
  • Patients with structural abnormality of the heart

Treatment and study plan

single trans-septal puncture

Procedure

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

conventional bilateral groin puncture

Procedure

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

Primary outcomes

  1. Patient's subjective discomfort

    Time frame: 6month after procedure

Secondary outcomes

  1. Procedure time

    Time frame: 1day

  2. Procedure related complication rate

    Time frame: 1 month after procedure

  3. Long-term AF recurrence rate

    Time frame: 12 month after procedure

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 8, 2015
Registry last updated
Feb 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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