Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

April 11, 2023 updated by: Saint Luke's Health System

Quantification of Debris Captured Using Transcatheter Cerebral Embolic Protection (TCEP) During Valve in Valve Transcatheter Aortic Valve Replacement (VIV TAVR) With Bioprosthetic Valvular Fracture (BVF)

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

SENTINEL VIV-TAVR is a prospective, single-center, single-arm, unblinded pilot trial. A total of 20 subjects with severe symptomatic bioprosthetic aortic valve degeneration, who are deemed to be at high or prohibitive mortality risk related to surgical aortic valve replacement, and are undergoing VIV-TAVR and BVF, will be enrolled at the Mid-America Heart Institute, St-Luke's Hospital of Kansas City. Subjects will initially have an aortic arch angiogram done to confirm appropriate anatomy, followed by the SENTINEL device implanted through right radial artery approach. After that, patients will undergo VIV TAVR, using a commercially available transcatheter heart valve, followed by bioprosthetic valve fracture (BVF) as indicated.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital of Kansas City
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: VIV TAVR with BVF using TCEP
All subjects will receive the intervention.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantity of debris
Time Frame: During surgical procedure
Amount of debris captured by the SENTINEL TCEP device in VIV TAVR with BVF patients compared to historical data
During surgical procedure
Complication rate
Time Frame: Through hospital discharge, an average of 2.5 days
In-hospital stroke, device embolization rate, procedure-related major bleeding
Through hospital discharge, an average of 2.5 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: Through hospital discharge, an average of 2.5 days
Deaths from all causes
Through hospital discharge, an average of 2.5 days
MACCE
Time Frame: Through hospital discharge, an average of 2.5 days
Major adverse cardiac and cerebrovascular events
Through hospital discharge, an average of 2.5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Luke's Health System

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Adnan Chhatriwalla, MD, Saint Luke's Health System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

July 31, 2024

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

April 12, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-109

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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