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Recruiting
NCT06871774
Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
Conditions: Transcatheter Aortic Valve Replacement
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 300
Sponsor: Wake Forest University Health Sciences
Location: Aurora St. Luke's Medical Center Milwaukee Wisconsin
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.
Eligibility Criteria
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 (\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 \
Source: ClinicalTrials.gov (NCT06871774). StuddyBuddy aggregates publicly available trial information.