An interventional study of Single Perclose Pro vascular closure device and Dual Perclose vascular closure device in Transcatheter Aortic Valve Replacement, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Treatment
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.
This single-center randomized trial compares single versus dual Perclose devices for pre-closure of vascular access for Transcatheter Aortic Valve Replacement (TAVR) and investigation will evaluate the efficacy and performance of these two pre-closure approaches. The study will provide valuable insights into optimizing pre-closure techniques, potentially enhancing patient outcomes and reducing complications associated with Transcatheter Aortic Valve Replacement (TAVR) procedures. The trial will aim to enroll patients undergoing TAVR, with an an equal number of patients randomized to each pre-closure strategy arm.
231 studies on the registry are indexed under Aortic Valve Disease; 76 are open to participants now.
This study's planned enrollment of 300 is above the median of 108 across 116 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
A single Perclose device will be used for pre-closure of the vascular access site, with manual pressure and up to two additional devices used as needed to achieve hemostasis.
Device: Single Perclose Pro vascular closure device
Two Perclose devices will be used for pre-closure of the vascular access site, with manual pressure and an additional device used as needed to achieve hemostasis.
Device: Dual Perclose vascular closure device
Use of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.
Use of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.
Number of Patients With Vascular Complications
Number of subjects in each group experiencing major or minor vascular complications directly related to the TAVR procedure occurring during the index hospitalization.
Time frame: Day 5 post-procedure
Number of Patients With Life-threatening bleeding
Number of subjects in each group experiencing any bleeding event related to the TAVR procedure that is life-threatening within 24 hours post-procedure.
Time frame: Hour 24 post-procedure
Number of Patients With Major or Minor Bleeding Complications Without Life-Threatening Condition
Number of subjects in each group experiencing bleeding complications related to the TAVR procedure that do not meet the criteria for life-threatening bleeding but still result in significant clinical concern within 24 hours of the index procedure.
Time frame: Hour 24 post-procedure
Time to Hemostasis
For each subject, time elapsed from initial deployment of the initial one or two Perclose devices (depending on assigned group) to complete hemostasis of the femoral access site. Measured in seconds.
Time frame: 1 hour post procedure
Additional Closure Device Use
Number of subjects requiring use of additional closure devices beyond the initial closure strategy required to achieve hemostasis at the femoral access site within 24 hours post-procedure. The number and type of devices will be recorded for each subject.
Time frame: Hour 24 post-procedure
In-Hospital Serious Vascular Complications Requiring Percutaneous or Surgical Interventions
Number of subjects in each group experiencing severe vascular complications that necessitate either percutaneous procedures or surgical interventions during the index hospitalization.
Time frame: Day 5 post-procedure
Number of Patients With Limb Ischemia Related to TAVR During Index Admission
Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure between the TAVR procedure and discharge.
Time frame: Day 5 post-procedure
Limb Ischemia Related to TAVR
Number of subjects in each group experiencing significant peripheral ischemia related to the arteriotomy closure monitored within 30 days post procedure.
Time frame: Day 30 post-procedure
Plan to share: No
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Wake Forest University Health Sciences