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

Atrial Fibrillation Clinical Trial

— SAFE-VEIN  

Official title:

Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial: A Randomized, Prospective Study of the Safety and Efficacy of Venous Closure Device Compared to Conventional Closure Strategies in Post Venous Access Procedures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04632641
• Other study ID #: 20-235
• Status: Completed
• Phase: N/A
• Start date: April 23, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2024
• Source: Aurora Health Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Large-bore (>13F) Venous Access Procedures 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 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)

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter
• Brady-tachy Syndrome
• Bradycardia
• Embolism
• Embolism and Thrombosis
• Heart Block
• Mitral Valve Repair
• Pulmonary Embolism
• Pulmonary Embolism and Thrombosis
• Sick Sinus Syndrome
• Sinus Node Dysfunction
• Thrombosis

Intervention

Device:
• Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES
The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.

Other:
• Figure 8 Suture - LARGE-BORE PROCEDURES
A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.

Locations

Country	Name	City	State
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Aurora Health Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Achieve Hemostasis	The elapsed time between "device" removal and first observed and confirmed venous hemostasis	Day 1
Primary	Time to Ambulate	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.	Day 1
Secondary	Time to Discharge (TTD)/Length of Stay (LOS)	The elapsed time between removal of the final sheath, and the ability of subjects to be discharged. Total length of hospital stay.	up to 5 days post procedure
Secondary	Post Procedure Major Bleeding	Bleeding associated with =2 g/dl drop in hemoglobin level requiring transfusion, bleeding that occurs at a critical site, or bleeding contributing to death.	up to 30 days post procedure
Secondary	Minor Bleeding	Any bleeding that does not meet the criteria for major bleeding	up to 30 days post procedure
Secondary	Access Site Complications	Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV (arteriovenous) fistula	up to 30 days post procedure
Secondary	Mortality	Mortality due to vascular complications	up to 30 days post procedure