VEnous cLOsure vs. FIgRE of 8 suture after AF ablation: the VELOFIRE randomized trial
NCT ID NCT07814144
First seen Sep 10, 2026 · Last updated Sep 10, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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90 people
The number who actually took part.
- Started
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Jan 2026
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥19 years or legal age to provide informed consent under Korean law. 2. Scheduled for atrial fibrillation catheter ablation using unilateral femoral venous access with a sheath ≥8 Fr. 3. Bilateral femoral venous anatomy suitable for application of the Perclose ProGlide™ suture-based vascular closure device. 4. Written informed consent and agreement to post-procedural follow-up and outpatient visits. 5. Considered able to complete follow-up during the study period. Exclusion Criteria: 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. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Yonsei University College of Medicine
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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