Clinical trial NCT04632641: Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Atrial Flutter
Heart Block
Pulmonary Embolism and Thrombosis
Mitral Valve Repair
Sinus Node Dysfunction
Bradycardia
Brady-tachy Syndrome
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-11-17
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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)

Primary outcomes:
measure: Time to Achieve Hemostasis
timeFrame: Day 1
measure: Time to Ambulate
timeFrame: Day 1
Secondary outcomes:
measure: Time to Discharge (TTD)/Length of Stay (LOS)
timeFrame: up to 5 days post procedure
measure: Post Procedure Major Bleeding
timeFrame: up to 30 days post procedure
measure: Minor Bleeding
timeFrame: up to 30 days post procedure
measure: Access Site Complications
timeFrame: up to 30 days post procedure
measure: Mortality
timeFrame: up to 30 days post procedure
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Mohammad E Mortada, MD
role: PRINCIPAL_INVESTIGATOR
References: