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

NCT04632641 | Completed Results FDA Device

• 1 other identifier: 20-235
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Time to Discharge (TTD)/Length of Stay (LOS)

  up to 5 days post procedure

• Post Procedure Major Bleeding

  up to 30 days post procedure

• Minor Bleeding

  up to 30 days post procedure

• Access Site Complications

  up to 30 days post procedure

• Mortality

  up to 30 days post procedure

Study Arms (2)

Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES

EXPERIMENTAL

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

Figure 8 Suture - LARGE-BORE PROCEDURES

ACTIVE COMPARATOR

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

Interventions

Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES DEVICE

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.

Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES

Figure 8 Suture - LARGE-BORE PROCEDURES OTHER

A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.

Figure 8 Suture - LARGE-BORE PROCEDURES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

Related Publications (1)

• Ali M, Masood F, Erickson L, Adefisoye J, Kanani J, Walczak S, Ajam T, Kieu A, Premjee M, Jan MF, Allaqaband SQ, Bajwa T, Khitha J, Zilinski J, Jahangir A, Djelmami-Hani M, Sra J, Niazi I, Mortada ME. Suture closure AFtEr large bore vein access (SAFE-VEIN): A randomized, prospective study of the efficacy and safety of venous closure device. Catheter Cardiovasc Interv. 2024 Oct;104(4):820-828. doi: 10.1002/ccd.31173. Epub 2024 Aug 1.

  PMID: 39087741 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter; Heart Block; Pulmonary Embolism; Thrombosis; Sick Sinus Syndrome; Bradycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Conduction System Disease; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Arrhythmia, Sinus

Results Point of Contact

• Title: Dr. Mahmoud Ali
• Organization: Aurora Health Care

mahmoud.ali@aah.org

(262) 948-6630

Study Officials

• Mohammad E Mortada, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 17, 2020
• Study Start: April 23, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: October 3, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-04

Locations

US (1)