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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.