Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial

Not Applicable

Completed

• Conditions: Heart Block; Pulmonary Embolism and Thrombosis; Sinus Node Dysfunction; Atrial Fibrillation; Atrial Flutter; Mitral Valve Repair; Brady-tachy Syndrome; Bradycardia
• Interventions: Device: Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES; Other: Figure 8 Suture - LARGE-BORE PROCEDURES

• Registration Number: NCT04632641
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Primary objective: To compare the safety and efficacy of closure strategies post venous access procedures.

Hypothesis: We anticipate that the use of a venous closure device will decrease the time to hemostasis (TTH), time to ambulation (TTA) and time to discharge (TTD) compared to conventional methods of closure following venous access procedure.

Detailed Description

This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC (Aurora St. Luke's Medical Center):

Large-Bore Procedures \>13 F

1. WATCHMAN® device placement

2. Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon

3. Leadless pacemaker

4. Pulmonary embolism thrombectomy (Inari FlowTriever system)

5. MitraClip transcatheter mitral valve repair

RANDOMIZATION:

Patients will be randomized into one of two venous closure groups after a clean stick has been achieved with no complications:

Large-bore (14F-25F) venous access group (1:1)

* Perclose ProGlide SMC

* Figure 8 suture

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-11-11
• Study First Submitted QC: 2020-11-11
• Study First Posted: 2020-11-17
• Study Start: 2021-04-23
• Primary Completion: 2022-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-04
• Results First Submitted: 2024-04-19
• Results First Submitted QC: 2024-04-19
• Results First Posted: 2024-05-16
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

Inclusion Criteria

All patients 18 years and older who are undergoing any of the following: WATCHMAN® device placement, atrial fibrillation ablation using cryoballoon or laser balloon, leadless pacemaker, Pulmonary embolism thrombectomy (Inari FlowTriever system), MitraClip transcatheter mitral valve repair at Aurora St. Luke's Medical Center from date of IRB (Institutional Review Board) approval through December 2022. All arterial line access should be radial.

Exclusion criteria:

Large-bore (>13F) Venous Access Procedures

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Exclusion Criteria

• Patients in whom introducer sheaths >25F were used in the vein during the catheterization procedure.
• Patients with small femoral arteries or veins (< 5 mm in diameter).
• Patients with access sites in vascular grafts.
• Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
• Patients who have complications during the procedure not related to the Perclose ProGlide SMC closure device
• The physician determines that they must use an alternate method as the primary venous closure method other than that which the patient was randomized to
• Active systemic or cutaneous infection, or inflammation in vicinity of the groin
• Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
• Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count < 100,000 cells/mm3
• Severe co-existing morbidities with life expectancy less than 12 months
• Femoral arteriotomy or femoral venotomy in < 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days
• Planned femoral venous or arterial access within next 30 days
• Unable to routinely walk at least 20 ft. without assistance
• LMWH (low molecular weight heparin) within 8 hours before or after procedure
• Pregnant and/or lactating women
• Extreme morbid obesity (BMI > 40 kg/m2) or underweight (BMI < 20 kg/m2)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES	Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES	Perclose ProGlide Suture-Mediated Closure System (SMC) will be used as closure strategy for venous access sites using sheath sizes greater than 13F.
Figure 8 Suture - LARGE-BORE PROCEDURES	Figure 8 Suture - LARGE-BORE PROCEDURES	Figure 8 suture will be used as a closure technique for venous access sites using sheath sizes greater than 13F.

Primary Outcome Measures

Name	Time	Method
Time to Ambulate	Day 1	The elapsed time between removal of the final Perclose ProGlide SMC device (treatment arm) or removal of the final sheath (control arm), and the ability of subjects to stand and ambulate 20 feet without evidence of venous re-bleeding from the femoral access sites.
Time to Achieve Hemostasis	Day 1	The elapsed time between "device" removal and first observed and confirmed venous hemostasis

Secondary Outcome Measures

Name	Time	Method
Time to Discharge (TTD)/Length of Stay (LOS)	up to 5 days post procedure	The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.
Minor Bleeding	up to 30 days post procedure	Any bleeding that does not meet the criteria for major bleeding
Mortality	up to 30 days post procedure	Mortality due to vascular complications
Access Site Complications	up to 30 days post procedure	Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula
Post Procedure Major Bleeding	up to 30 days post procedure	Bleeding associated with ≥2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.

Trial Locations

Locations (1)

Aurora St. Luke's Medical Center; 🇺🇸 Milwaukee, Wisconsin, United States