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

Wake Forest University (WFU)

Status

Completed

Conditions

Bradycardia

Mitral Valve Repair

Atrial Flutter

Atrial Fibrillation

Brady-tachy Syndrome

Sinus Node Dysfunction

Heart Block

Pulmonary Embolism and Thrombosis

Treatments

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

Other: Figure 8 Suture - LARGE-BORE PROCEDURES

Study type

Interventional

Funder types

Other

Identifiers

NCT04632641

20-235

Details and patient eligibility

About

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.

Full 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

WATCHMAN® device placement
Atrial fibrillation/flutter/SVT (supraventricular tachycardia) ablation using cryoballoon or laser balloon
Leadless pacemaker
Pulmonary embolism thrombectomy (Inari FlowTriever system)
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

Enrollment

107 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)