Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR (NCT06871774) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
United States300 participantsStarted 2025-06-16
Plain-language summary
This study will compare the use of one Perclose device to the usual approach of two devices for pre-closure during Transcatheter Aortic Valve Replacement (TAVR). The study will compare the time it takes for bleeding to stop using the different closure approaches. The study will also compare complications when using one Perclose device versus two.
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:
* Patient age 18 or older
* Transfemoral transcatheter aortic valve replacement (TAVR)
* Implantation of CoreValve replacement valve
* Access using 14 French sheaths
* English speaking
Exclusion Criteria:
* Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian access or transapical access.
* Planned Surgical Cut-Down: Patients planned for surgical cut-down procedures rather than percutaneous access.
* Vascular Access Complications: Patients with known vascular complications at the femoral access site, such as residual hematoma, recent femoral arteriotomy or venotomy within the past 10 days, history of significant vascular complications or prior intravascular closure device use within the previous 30 days.
* Arterial or Venous Issues: Patients with small femoral arteries or veins (\<5 mm in diameter), patients with access sites located in vascular grafts.
* Body Composition: Patients with BMI \>35
* Cardiac Vasculature: Patients with excess calcification of vessels as determined by echocardiography and/or CT angiography
* Infection or Inflammation: Active systemic or cutaneous infection or inflammation in the vicinity of the groin.
* Coagulation and Hematological Disorders: Known history of bleeding diathesis, coagulopathy, hypercoagulability, or platelet count \<100,000 cells/mm³. Pre-existing immunodeficiency disorder or chronic use of high-dose systemic steroids.
*…
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.
What they're measuring
1
Number of Patients With Vascular Complications
Timeframe: Day 5 post-procedure
2
Number of Patients With Life-threatening bleeding
Timeframe: Hour 24 post-procedure
3
Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition