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

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

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.

Study Overview

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

Detailed Description

This study will be a prospective, randomized study of patients who are undergoing one or more of the following procedures at ASLMC:

Large-Bore Procedures >13 F

1. WATCHMAN® device placement
2. Atrial fibrillation/flutter/SVT 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

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud Ali, MD; Phone Number: (414) 222-9892; Email: Mahmoud.Ali@aah.org

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53215
      • Recruiting
      • Aurora St. Luke's Medical Center
      • Contact: Mahmoud Ali, MD; Phone Number: 414-222-9892; Email: mahmoud.ali@aah.org
      • Principal Investigator: Mohammad E Mortada, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to achieve hemostasis	The elapsed time between "device" removal and first observed and confirmed venous hemostasis	Day 1
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Minor bleeding	Any bleeding that does not meet the criteria for major bleeding	up to 30 days post procedure
Access site complications	Access site hematoma, vascular thrombosis, vascular dissection, pseudoaneurysm, or AV fistula	up to 30 days post procedure
Mortality	Mortality due to vascular complications	up to 30 days post procedure

Collaborators and Investigators

• Sponsor: Aurora Health Care
• Investigators: Principal Investigator: Mohammad E Mortada, MD, Aurora Health Care

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 11, 2020
• First Submitted That Met QC Criteria: November 11, 2020
• First Posted (Actual): November 17, 2020

Study Record Updates

• Last Update Posted (Actual): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Arrhythmia, Sinus; Embolism; Atrial Fibrillation; Heart Block; Bradycardia; Thrombosis; Atrial Flutter; Pulmonary Embolism; Sick Sinus Syndrome; Embolism and Thrombosis
• Other Study ID Numbers: 20-235

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes