RECRUITING

Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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)

Quick Facts

Study Start:2022-03-02

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05093764

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: * 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.	* 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

Inclusion Criteria

Exclusion 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:
* 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.

* 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

Contacts and Locations

Study Contact

Sheila Erwin, RN

CONTACT

816-932-7996

serwin@saintlukeskc.org

Principal Investigator

Adnan Chhatriwalla, MD

PRINCIPAL_INVESTIGATOR

Saint Luke's Health System

Study Locations (Sites)

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, 64111

United States

Collaborators and Investigators

Sponsor: Saint Luke's Health System

Adnan Chhatriwalla, MD, PRINCIPAL_INVESTIGATOR, Saint Luke's Health System

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 Registration Dates

Study Start Date2022-03-02

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2022-03-02

Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

Aortic Valve Disease