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Device
TCEP in VIV TAVR for Aortic Valve Disease
N/A
Recruiting
Led By Adnan Chhatriwalla, MD
Research Sponsored by Saint Luke's Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The patient has severe bioprosthetic aortic valve degeneration (stenosis, insufficiency, or mixed valve disease) and a clinical indication for VIV TAVR
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through hospital discharge, an average of 2.5 days
Awards & highlights
Study Summary
This trial is investigating how well a SENTINEL transcatheter cerebral embolic protection (TCEP) device works in patients undergoing valve in valve transcatheter aortic valve replacement (VIV TAVR) with bioprosthetic valvular fracture (BVF).
Who is the study for?
This trial is for adults over 18 with severe degeneration of a previously placed artificial aortic valve who need a new non-surgical valve replacement. Candidates must have suitable blood vessel anatomy, be able to give informed consent, and commit to follow-up visits. They should not have had recent strokes, significant artery narrowing, certain heart conditions or be pregnant.Check my eligibility
What is being tested?
The study measures debris caught by the SENTINEL device during a special non-surgical procedure (VIV TAVR) that replaces failing artificial heart valves and uses balloon fracturing (BVF). The goal is to understand how much debris this protection device captures during the process.See study design
What are the potential side effects?
While specific side effects are not listed here, procedures like VIV TAVR can include risks such as bleeding, blood vessel complications, stroke risk due to loosened debris and general anesthesia-related issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve replacement is failing and I need a procedure to fix it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during surgical procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during surgical procedure
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complication rate
Quantity of debris
Secondary outcome measures
MACCE
Mortality
Trial Design
1Treatment groups
Experimental Treatment
Group I: VIV TAVR with BVF using TCEPExperimental Treatment1 Intervention
All subjects will receive the intervention.
Find a Location
Who is running the clinical trial?
Saint Luke's Health SystemLead Sponsor
41 Previous Clinical Trials
12,926 Total Patients Enrolled
Boston Scientific CorporationIndustry Sponsor
719 Previous Clinical Trials
932,902 Total Patients Enrolled
2 Trials studying Aortic Valve Disease
111 Patients Enrolled for Aortic Valve Disease
Adnan Chhatriwalla, MDPrincipal InvestigatorSaint Luke's Health System
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart valve replacement is failing and I need a procedure to fix it.I can understand and am willing to sign the consent form.The artificial valve could break if inflated with a high-pressure balloon.You have a narrowed artery in the right side of your chest.You have a blood clot in your left atrial appendage, as seen on certain imaging tests.I can and will come back for all needed follow-ups and tests.You are expected to live for less than one year.You need to have a CT angiogram of your chest, abdomen, and pelvis to make sure the blood vessels in your legs and around your heart and brain are suitable for the procedure.I am not currently in a trial for a heart device or new drug, except for approved studies.My right radial artery was used for a past heart bypass surgery.My heart valve replacement cannot be modified with standard treatment.I have been diagnosed with a significant narrowing (50% or more) of my carotid artery.You have a condition with your aortic arch that makes it impossible to use the SENTINEL device.Doctors have determined that it's too risky for the patient to have surgery to replace the aortic valve.I am 18 years old or older.I had a stroke or similar brain event in the last 6 months.I am at low or moderate risk from heart valve surgery.I have a dialysis fistula or graft in my right arm/forearm.
Research Study Groups:
This trial has the following groups:- Group 1: VIV TAVR with BVF using TCEP
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have volunteered to participate in this clinical experiment?
"That is correct. According to records on clinicaltrials.gov, this medical experiment was first published on March 2nd 2022 and is still taking enrolment applications at present. To complete the trial, 20 participants need to be sourced from a single site."
Answered by AI
Are there any vacancies available to participants in this clinical trial?
"This research endeavor is actively recruiting participants, as per the clinicaltrials.gov records. It was initially posted on March 2nd 2022 and its most recent update occurred on April 8th of the same year."
Answered by AI
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