NCT04632641Completed
Suture Closure AFtEr VEIN Access for Cardiac Procedures (SAFE-VEIN) Trial
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
Source: ClinicalTrials.gov · Last updated 3 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 107 (actual)
- First submitted
- 11 Nov 2020
- Start date
- 23 Apr 2021
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Atrial fibrillation
- NCT number
- NCT04632641
What you commit to
- Study type: Interventional
- Participants enrolled: 107
- From 23 Apr 2021 to the primary completion date, 31 Dec 2022
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with intra-procedural bleeding around access site. Patients who cannot receive radial arterial line access.
- Active systemic or cutaneous infection, or inflammation in vicinity of the groin
- Pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids
Lab values
- Known history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count \< 100,000 cells/mm3
Other
- 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 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
- Severe co-existing morbidities with life expectancy less than 12 months
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aurora St. Luke's Medical Center Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.