Comparison of Single vs. Dual Perclose Devices for Large-Bore Access Closure in TAVR
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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
Qualifiers
Patient age 18 or older
Transfemoral transcatheter aortic valve replacement (TAVR)
Implantation of CoreValve replacement valve
Access using 14 French sheaths
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Single Perclose Pro vascular closure device
- Dual Perclose vascular closure device
Treatment groups
300 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov