Recruiting

Debris Quantification

Sponsor:

Saint Luke's Health System

Code:

NCT05093764

Conditions

Aortic Valve Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

VIV TAVR with BVF using TCEP

Study Details

Brief summary:

The objective of this study is to quantify the amount of debris captured by the SENTINEL transcatheter cerebral embolic protection (TCEP) device in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF)

Conditions

Aortic Valve Disease

Study ID

NCT05093764

Start date

Mar 2, 2022

Status verified date

Jun, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Men and Women ≥ 18 years of age
  • The patient has severe bioprosthetic aortic valve degeneration (stenosis, insufficiency, or mixed valve disease) and a clinical indication for VIV TAVR
  • The bioprosthetic valve can be fractured with high pressure balloon inflation.
  • The patient is deemed at prohibitive or high mortality risk related to surgical aortic valve replacement as assessed by the Heart Team
  • For procedural planning, all patients must have a CT angiogram of the chest, abdomen and pelvis to confirm:

A. Adequate femoral access for the TAVR procedure B. Appropriate right subclavian, carotid and brachiocephalic as well as left carotid artery anatomy for the SENTINEL device deployment.

  • The patient or legal representative is able to understand and willing to provide written informed consent to participate in the trial
  • The patient is able and willing to return for required follow-up visits and examinations
  • The patient is evaluated by the multidisciplinary heart-valve team and found to be a suitable for the procedure.

Exclusion Criteria:

  • Patients with low or moderate mortality risk from surgical aortic valve replacement
  • Patients with bioprosthetic valves that cannot be fractured with standard non-compliant valvuloplasty balloons (Table 1)
  • Patients with evidence of significant carotid artery stenosis (i.e., carotid stenosis ≥ 50%), noted on ultrasound duplex imaging or CT angiography.
  • Patients with evidence of right subclavian/brachiocephalic artery stenosis
  • Patients with right arm/forearm dialysis fistula or graft.
  • Patients with harvested right radial artery for a previous coronary bypass surgery.
  • Patients with prohibitive aortic arch anomalies for SENTINEL device implantation.
  • The patient with history of cerebrovascular event (CVA) within within 6 months.
  • Patient with incidental left atrial appendage thrombus noted on TEE or CT imaging.
  • The patient is actively enrolled in another trial of a cardiovascular device or an investigational drug (post-market study participation and registries are acceptable)
  • The patient is pregnant, or pregnancy is planned during the course of the investigation if patient is of child-bearing potential
  • Any clinically significant medical condition or presence of any laboratory abnormality performed prior to randomization that is considered by the investigator to be clinically important and could interfere with the conduct of the study or not meeting procedure guidelines for TAVR or SENTINEL
  • The patient has a life expectancy of less than one year

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: VIV TAVR with BVF using TCEP

All subjects will receive the intervention.

Interventions

VIV TAVR with BVF using TCEP

The insertion and retrieval of the SENTINEL device is performed at the time of the patients TAVR procedure in the same setting while they are sedated under moderate sedation or general anesthesia depending on the case. The device is inserted at the initiation of the procedure through 6F right radial artery access and the filters are positioned in the left common carotid artery and brachiocephalic artery. After deployment, the usual TAVR procedure is performed. At the conclusion of the procedure, the SENTINEL device is extracted and hemostasis is achieved at the radial access site in the usual fashion with patent hemostasis.

Primary outcome measure

  • Quantity of debris [ Time Frame: During surgical procedure ]
  • Complication rate [ Time Frame: Through hospital discharge, an average of 2.5 days ]

Central Contacts and Locations

Central contacts

Sheila Erwin, RN

816-932-7996serwin@saintlukeskc.org

Locations

Saint Luke's Hospital of Kansas City

Recruiting

Kansas City, Missouri, United States, 64111

Contacts

Sheila Erwin, RN

816-932-7996serwin@saintlukeskc.org

Principal Investigator:

Adnan Chhatriwalla, MD

More Information

Sponsor

Saint Luke's Health System

Last update posted

Jun 14, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Saint Luke's Health System on 2024-06-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.