What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Valvular Heart Disease, such as Transcatheter Aortic Valve Replacement (TAVR), can have several side effects. These include bleeding, vascular complications, stroke, and arrhythmias. Specific to procedures like the TELLTALE guidewire system, which involves cutting the leaflet to prevent coronary artery obstruction, there is a risk of leaflet damage, coronary artery obstruction, and potential complications from the use of guidewires and other devices. Patients may also experience general procedural risks such as infection, anesthesia-related complications, and issues related to the placement and function of the new valve.

What prior FDA approvals exist?

The FDA has approved several treatments for Valvular Heart Disease, particularly focusing on transcatheter aortic valve replacement (TAVR) procedures. Notable FDA-approved devices include the Edwards SAPIEN valve and the Medtronic CoreValve, both designed for TAVR to treat severe aortic stenosis. These devices help replace the aortic valve without open-heart surgery. Additionally, adjunctive devices like the Sentinel Cerebral Protection System have been approved to reduce the risk of stroke during TAVR. While specific devices designed to cut the leaflet during TAVR to prevent coronary artery obstruction, such as the TELLTALE guidewire system, are still under investigation, these existing approvals highlight the advancements in minimally invasive treatments for valvular heart conditions.

What other types of research exist?

Promising alternatives to the TELLTALE guidewire system for preventing coronary artery obstruction during TAVR include: 1) BASILICA (Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction) procedure, which uses electrosurgery to lacerate the leaflet; 2) Advanced imaging techniques and pre-procedural planning tools, such as 3D-printed models and computational simulations, to better predict and prevent coronary obstruction; 3) Newer generation TAVR devices with improved design features to minimize the risk of leaflet displacement and coronary obstruction. These alternatives are being actively researched and may offer enhanced safety and efficacy for patients undergoing TAVR.

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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

No Placebo-Only Group

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 below

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I am 21 years old or older.

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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:

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My heart valve has severe calcium buildup shown on a CT scan.

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I have advanced kidney disease or am on dialysis.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon discharge from the index hospital admission for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Inpatient safety

The efficacy of the TELLTALE guidewire

Secondary study objectives

30-day safety

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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)

0 / 5Eligibility criteria met

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].