NCT02438176

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
25 days until next milestone

Study Start

First participant enrolled

June 2, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2018

Completed
Last Updated

February 26, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

May 3, 2015

Last Update Submit

February 25, 2019

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Patient's subjective discomfort

    6month after procedure

Secondary Outcomes (3)

  • Procedure time

    1day

  • Procedure related complication rate

    1 month after procedure

  • Long-term AF recurrence rate

    12 month after procedure

Study Arms (2)

single puncture group

EXPERIMENTAL

single trans-septal puncture

Procedure: single trans-septal puncture

conventional group

ACTIVE COMPARATOR

conventional bilateral groin puncture

Procedure: conventional bilateral groin puncture

Interventions

single trans-septal puncturePROCEDURE

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

single puncture group
conventional bilateral groin puncturePROCEDURE

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

conventional group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • persistent AF
  • Patients with vascular disease or venous anomaly
  • Patients with structural abnormality of the heart

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Cardiovascular Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2015

First Posted

May 8, 2015

Study Start

June 2, 2015

Primary Completion

March 9, 2018

Study Completion

March 9, 2018

Last Updated

February 26, 2019

Record last verified: 2019-02

Locations

KR(1)