Atrial FibrillationPhase 4NCT07814144
Venous Closure System After AF Ablation
A Phase 4 study testing Perclose ProGlide™ and Figure-of-8 suture in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Perclose ProGlide™ and Figure-of-8 suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Jan 2026to 31 Aug 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
- Platelet count <100,000/mm³.
- History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis.
- Moderate or greater anemia (hemoglobin ≤10 g/dL).
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- Hemodynamic or electrical instability.
- Body mass index >45 kg/m² or <20 kg/m².
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VEnous cLOsure vs. FIgRE of 8 Suture After AF Ablation: The VELOFIRE Randomized Trial
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Perclose ProGlide™, Figure-of-8 suture
- Keywords
- Atrial fibrillation, catheter ablation, venous closure, vascular closure device, Perclose ProGlide, figure-of-8 suture, hemostasis
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perclose ProGlide™Procedure or surgery
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.
Figure-of-8 sutureProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Venous Closure System | Experimental | Participants will undergo standard PVI with additional patient-specific ablation targeting stable atrial fibrillation drivers identified by the digital twin model, followed by protocol-specified rhythm monitoring. Receives: Procedure: Perclose ProGlide™ |
| Figure-of-8 Suture | Active comparator | Participants will undergo conventional figure-of-8 suture closure of the femoral venous access site after atrial fibrillation catheter ablation. Receives: Procedure: Figure-of-8 suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Procedural Patient Satisfaction Score
Patient satisfaction with the vascular closure method will be assessed using the protocol-specified Post-Procedural Patient Satisfaction Questionnaire. The total score ranges from 0 to 60 points and will be compared between randomized groups.
Measured: Periprocedural
Secondary outcomes (4)
Time to Hemostasis
Time required to achieve hemostasis after completion of the catheter ablation procedure will be compared between randomized groups.
Measured: Periprocedural
Time to Ambulation
Time until the participant can stand and walk 6 meters without painful swelling requiring analgesia, superficial bleeding, or tissue bruising at the access site.
Measured: Periprocedural
Time to Hospital Discharge
Time from the index procedure to hospital discharge will be compared between randomized groups.
Measured: Periprocedural
Minor and Major Vascular Complications
Incidence of minor and major vascular access-site complications occurring within 30 days after the procedure.
Measured: Within 30 days after the index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start6 Jan 2026
- Primary completion4 Jun 2026
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814144
- Sponsor's protocol ID
- 4-2025-1238
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VEnous cLOsure vs. FIgRE of 8 Suture After AF Ablation: The VELOFIRE Randomized Trial
- ClinicalTrials.gov ID
- NCT07814144
- Acronym / sponsor ID
- 4-2025-1238
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, catheter ablation, venous closure, vascular closure device, Perclose ProGlide, figure-of-8 suture, hemostasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 4 Jun 2026 (actual)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venous Closure System | Experimental | Procedure: Perclose ProGlide™Participants will undergo standard PVI with additional patient-specific ablation targeting stable atrial fibrillation drivers identified by the digital twin model, followed by protocol-specified rhythm monitoring. |
| Figure-of-8 Suture | Active comparator | Procedure: Figure-of-8 sutureParticipants will undergo conventional figure-of-8 suture closure of the femoral venous access site after atrial fibrillation catheter ablation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
- Platelet count <100,000/mm³.
- History of deep vein thrombosis, pulmonary embolism, or thrombophlebitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Venous Closure System |
| Figure-of-8 sutureAt 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. | Procedure or surgery | Figure-of-8 Suture |
Primary outcome
Post-Procedural Patient Satisfaction Score
Time frame: Periprocedural
Patient satisfaction with the vascular closure method will be assessed using the protocol-specified Post-Procedural Patient Satisfaction Questionnaire. The total score ranges from 0 to 60 points and will be compared between randomized groups.
4 secondary outcomes
Time to Hemostasis
Time frame: Periprocedural
Time to Ambulation
Time frame: Periprocedural
Time to Hospital Discharge
Time frame: Periprocedural
Minor and Major Vascular Complications
Time frame: Within 30 days after the index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Perclose ProGlide™ and Figure-of-8 suture in people with Atrial Fibrillation, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Procedural Patient Satisfaction Score (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.