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Study of Debris Capture During VIV TAVR with BVF

This study is looking at how much debris the SENTINEL device can capture during a procedure called VIV TAVR with BVF. VIV TAVR (Valve-in-Valve Transcatheter Aortic Valve Replacement) is a way to replace a failing artificial heart valve without open-heart surgery, and BVF (bioprosthetic valvular fracture) is a step where the old valve is fractured. The SENTINEL device is inserted during your TAVR procedure while you are sedated. We want to see how much debris is collected during the procedure and track any complications until you leave the hospital. You might be able to join if you are 18 or older, have severe aortic valve disease, and are having VIV TAVR with BVF. This study is currently unclear on its recruitment status and plans to enroll 20 participants.

Study design
This is a small, single-center study involving 20 participants. It is a single-arm study, meaning all participants receive the same intervention, and it is unblinded.
What's involved
You would undergo the insertion and retrieval of the SENTINEL device during your VIV TAVR procedure. This happens while you are sedated.
Compensation
Not stated in the trial record.
Follow-up
Your complication rate will be measured through hospital discharge, which is an average of 2.5 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05093764

Quantification of Debris Captured Using TCEP During VIV TAVR With BVF

UNKNOWN
NAAges 18+InterventionalTreatment
Saint Luke's Health System
~20 participants
Updated 2024-06-14 on ClinicalTrials.gov
What's tested:VIV TAVR with BVF using TCEP

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Quantity of debris
Measured over During surgical procedure
+1 more outcome measured

Conditions

Aortic Valve Disease

Explore related trials

Aortic Valve Disorder

Where it's being run

1 sites across 1 states
Missouri1

Study leadership

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

Who to contact

Sheila Erwin, RN
[email protected]
816-932-7996
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Quantity of debrisDuring surgical procedure

    Amount of debris captured by the SENTINEL TCEP device in VIV TAVR with BVF patients compared to historical data

  • Complication rateThrough hospital discharge, an average of 2.5 days

    In-hospital stroke, device embolization rate, procedure-related major bleeding