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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Single Perclose Pro vascular closure device
DeviceUse of a single Perclose device for pre-closure of vascular access site after removal of TAVR sheath.
Dual Perclose vascular closure device
DeviceUse of two Perclose devices for pre-closure of vascular access site after removal of TAVR sheath.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Single DeviceExperimental treatment 1 intervention
Group B: Two deviceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-procedure2
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-procedure3
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-procedure4
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 procedureSecondary outcomes
1
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-procedure2
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-procedure3
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-procedure4
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-procedureSponsors and contacts
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Source ClinicalTrials.gov