Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial (NCT04632641) | Clinical Trial Compass
CompletedNot Applicable
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
United States107 participantsStarted 2021-04-23
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 …