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New treatment option for Transcatheter Aortic Valve Replacement
Official title Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
ClinicalTrials.gov ID: NCT06871774
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient age 18 or older
- Transfemoral transcatheter aortic valve replacement (TAVR)
- Implantation of CoreValve replacement valve
- Access using 14 French sheaths
- English speaking
You likely can't join if
- Alternative Access Routes: Patients undergoing transcatheter aortic valve replacement (TAVR) via alternative access routes such as subclavian 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...
- 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
See the full eligibility criteria
- Patient age 18 or older
- Transfemoral transcatheter aortic valve replacement (TAVR)
- Implantation of CoreValve replacement valve
- Access using 14 French sheaths
- English speaking
- 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...
- 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...
- Severe Morbidity: Severe co-existing morbidities with a life expectancy less than 12 months.
- Mobility Issues: Patients unable to routinely walk at least 20 feet without assistance.
- Recent Anticoagulation: Use of low molecular weight heparin (LMWH) within 8 hours before or after the procedure.
- Pregnancy and Lactation: Pregnant or lactating women.
- Incompatible Procedure Plan: Patients receiving the Edwards Sapien valve (Edwards Lifesciences, Irvine, CA)
- Contraindications: Patients with contraindications for the use of Perclose device.
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.