Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07814144
PHASE4

Venous Closure System After AF Ablation

Sponsor: Yonsei University

View on ClinicalTrials.gov

Summary

This prospective, randomized, participant-blinded study will compare a suture-based venous closure system (Perclose ProGlide™) with a conventional figure-of-8 suture for femoral venous access-site closure in patients undergoing catheter ablation for atrial fibrillation. A total of 90 participants will be randomized in a 1:1 ratio to the venous closure system group or the figure-of-8 suture group. The primary objective is to evaluate patient satisfaction with the post-procedural vascular closure strategy. Secondary outcomes include time to hemostasis, time to ambulation, time to discharge, and the incidence of minor and major vascular complications within 30 days. Participants will complete a post-procedural satisfaction questionnaire after suture removal, and vascular access-site complications will be assessed during hospitalization and follow-up through 30 days.

Official title: VEnous cLOsure vs. FIgRE of 8 Suture After AF Ablation: The VELOFIRE Randomized Trial

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2026-01-06

Completion Date

2027-08-31

Last Updated

2026-09-10

Healthy Volunteers

Yes

Interventions

PROCEDURE

Perclose ProGlide™

At the end of the procedure, Perclose ProGlide™ will be applied to femoral venous access sites using sheaths ≥8 Fr. Additional manual compression may be performed at the operator's discretion. A vertical mattress skin suture may be placed and removed the following day.

PROCEDURE

Figure-of-8 suture

At the end of the procedure, a figure-of-8 suture will be applied to the femoral venous access site, followed by manual compression as needed. The suture will be removed the following day.

Locations (1)

Yonsei University College of Medicine

Seoul, South Korea