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Procedure
BASILICA Procedure for Aortic Valve Stenosis
N/A
Recruiting
Led By Robert J Lederman, M.D.
Research Sponsored by National Heart, Lung, and Blood Institute (NHLBI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults age >= 21 years
Undergoing TAVR for bioprosthetic aortic valve failure or native aortic stenosis (on-label TAVR)
Must not have
Excessive target aortic leaflet calcification (no basal calcium-free window or potentially obstructive calcific masses) on baseline CT
Chronic kidney disease KDIGO stage 4 or 5 (eGFR < 29 ml/min/1.73m2) or renal replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at exit from the cardiac catheterization laboratory
Awards & highlights
Summary
This trial is testing a new device called TELLTALE, designed to make heart valve replacement surgery safer. It targets patients over 21 who are at high risk of blocked blood flow to the heart. The device cuts a tissue flap that can cause this blockage, aiming to reduce complications and improve patient outcomes. This type of heart valve replacement has emerged as an effective treatment option in patients with severe aortic stenosis, supported by a series of studies.
Who is the study for?
This trial is for adults aged 21 or older who need a heart valve replacement (TAVR) and are at high risk of coronary artery blockage during the procedure. Candidates must be considered likely to suffer from this complication based on CT analysis, agree to participate in all study procedures, and not expected to have other major health issues within the next year.
What is being tested?
The TELLTALE BASILICA procedure is being tested. It's a new device designed specifically for cutting a leaflet in the heart that can block blood flow during TAVR. The goal is to make this life-saving valve replacement surgery safer by preventing coronary artery obstruction.
What are the potential side effects?
While specific side effects aren't listed, general risks may include bleeding, infection, damage to heart structures from the guidewire system used in TELLTALE BASILICA procedure, as well as potential complications related to anesthesia.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 21 years old or older.
Select...
I am having TAVR for a failing heart valve or narrowed aortic valve.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My heart valve has severe calcium buildup shown on a CT scan.
Select...
I have advanced kidney disease or am on dialysis.
Select...
I need additional heart procedures during my valve replacement surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upon discharge from the index hospital admission
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upon discharge from the index hospital admission
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Inpatient safety
The efficacy of the TELLTALE guidewire
Secondary outcome measures
30-day safety
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Patients undergoing TAVR with BASILICA using the Transmural TELLTALE guidewire system for bioprosthetic aortic valve failure or native aortic stenosis ( on label TAVR)
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Valvular Heart Disease include surgical valve repair or replacement, and transcatheter aortic valve replacement (TAVR). TAVR, particularly with the use of devices like the TELLTALE guidewire system, involves inserting a new valve via a catheter and cutting the leaflet to prevent coronary artery obstruction.
This mechanism is crucial as it ensures unobstructed blood flow to the coronary arteries, reducing the risk of life-threatening complications. For VHD patients, these treatments are vital as they improve valve function, enhance blood flow, and significantly reduce symptoms and mortality associated with valve dysfunction.
[Interventional catheter treatment of tricuspid valve regurgitation].
[Interventional catheter treatment of tricuspid valve regurgitation].
Find a Location
Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)Lead Sponsor
3,889 Previous Clinical Trials
47,834,057 Total Patients Enrolled
3 Trials studying Valvular Heart Disease
876 Patients Enrolled for Valvular Heart Disease
Robert J Lederman, M.D.Principal InvestigatorNational Heart, Lung, and Blood Institute (NHLBI)
13 Previous Clinical Trials
755 Total Patients Enrolled
1 Trials studying Valvular Heart Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study's requirements and agree to follow them.The heart valve is not working properly at the beginning of the study.Needs a specific type of treatment called doppio (two-leaflet) BASILICA.I am scheduled for a stent placement in my heart's artery.My heart valve has severe calcium buildup shown on a CT scan.I am 21 years old or older.My heart team considers surgery for my aortic valve too risky.Needs a different entry point for treatment, not through the thigh.I have advanced kidney disease or am on dialysis.The doctors don't think you will live for another year.I am having TAVR for a failing heart valve or narrowed aortic valve.It's likely that you could have blockages in your coronary arteries during the TAVR procedure, based on a CT scan analysis by the NHLBI Core lab.A team of heart doctors decides that you are at high risk of having a blocked artery from the TAVR procedure.I need additional heart procedures during my valve replacement surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
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.
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