NCT07814144Active, not recruitingPhase 4
Venous Closure System After AF Ablation
VEnous cLOsure vs. FIgRE of 8 Suture After AF Ablation: The VELOFIRE Randomized Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (actual)
- First submitted
- 1 Sept 2026
- Start date
- 6 Jan 2026
- Primary completion date
- 4 Jun 2026
- Lead sponsor
- Yonsei University
- Diseases
- Atrial fibrillation
- NCT number
- NCT07814144
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 90
- From 6 Jan 2026 to the primary completion date, 4 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of prolonged hospitalization due to vascular access-related complications.
- History of vascular surgery involving the lower extremities or aorto-iliac axis.
- Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state).
- History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis.
Lab values
- Platelet count \<100,000/mm³.
- Moderate or greater anemia (hemoglobin ≤10 g/dL).
- Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.
- 1\. History of prolonged hospitalization due to vascular access-related complications.
- 2\. History of vascular surgery involving the lower extremities or aorto-iliac axis.
- 3\. Bleeding tendency (e.g., coagulation disorder or bleeding diathesis) or abnormal coagulation state (e.g., hypercoagulable state).
- 4\. Platelet count \<100,000/mm³. 5. History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis. 6. Moderate or greater anemia (hemoglobin ≤10 g/dL). 7. Hemodynamic or electrical instability. 8. Body mass index \>45 kg/m² or \<20 kg/m². 9. Severe renal impairment (eGFR \<30 mL/min/1.73 m²), except for patients receiving renal replacement therapy.
Other
- Hemodynamic or electrical instability.
- Body mass index \>45 kg/m² or \<20 kg/m².
Who the study is looking for
- Age ≥19 years or legal age to provide informed consent under Korean law.
- Scheduled for atrial fibrillation catheter ablation using unilateral femoral venous access with a sheath ≥8 Fr.
- Bilateral femoral venous anatomy suitable for application of the Perclose ProGlide™ suture-based vascular closure device.
- Written informed consent and agreement to post-procedural follow-up and outpatient visits.
- Considered able to complete follow-up during the study period.
Age in the registry: 19 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University College of Medicine Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.