Venous Closure System After AF Ablation

NCT07814144 | Active Not Recruiting Phase 4 DMC

• 1 other identifier: 4-2025-1238
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; catheter ablation; venous closure; vascular closure device; Perclose ProGlide; figure-of-8 suture; hemostasis

Outcome Measures

Primary Outcomes (1)

• 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.

  Periprocedural

Secondary Outcomes (4)

• Time to Hemostasis

  Periprocedural

• Time to Ambulation

  Periprocedural

• Time to Hospital Discharge

  Periprocedural

• Minor and Major Vascular Complications

  Within 30 days after the index procedure

Study Arms (2)

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.

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.

Procedure: Figure-of-8 suture

Interventions

Perclose ProGlide™ PROCEDURE

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.

Venous Closure System

Figure-of-8 suture PROCEDURE

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.

Figure-of-8 Suture

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.
• \. 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. 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.

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start: January 6, 2026
• Primary Completion: June 4, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)