What side effects are associated with this type of intervention?

The most common side effects of Transcatheter Aortic Valve Replacement (TAVR) for treating Bicuspid Aortic Valve include vascular complications, bleeding, stroke, and arrhythmias. Other potential side effects are kidney injury, infection, and issues related to the positioning or function of the valve, such as paravalvular leak. While TAVR is generally less invasive than surgical valve replacement, it still carries significant risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several Transcatheter Aortic Valve Replacement (TAVR) systems for the treatment of aortic stenosis, including in patients with bicuspid aortic valve anatomy. Notable devices include the Edwards SAPIEN and Medtronic CoreValve systems. These minimally invasive procedures offer an alternative to traditional surgical aortic valve replacement (SAVR), particularly for patients at intermediate or high surgical risk. The Medtronic TAVR system, currently under trial for low-risk patients with bicuspid aortic anatomy, represents ongoing advancements in this field.

What other types of research exist?

Promising alternatives to the Medtronic TAVR system for Bicuspid Aortic Valve patients include the Edwards SAPIEN 3 Ultra and the Boston Scientific ACURATE neo2. Both systems have shown positive outcomes in recent clinical trials and are designed to address the unique anatomical challenges of BAV. Additionally, the JenaValve Trilogy system, which is specifically designed for patients with aortic regurgitation and BAV, is another novel option expected to be available by 2024.

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Transcatheter Aortic Valve Replacement System

TAVR for Bicuspid Aortic Valve Disease

N/A

Waitlist Available

Led By Basel Ramlawi, MD

Research Sponsored by Medtronic Cardiovascular

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Bicuspid aortic valve anatomy (all sub-types) confirmed by MDCT

Severe aortic stenosis defined by specific criteria for symptomatic and asymptomatic patients

Must not have

Multivessel coronary artery disease with a Syntax score >22 and/or unprotected left main coronary artery

Anatomical exclusion criteria including pre-existing prosthetic heart valve, severe mitral or tricuspid regurgitation, moderate or severe mitral stenosis, hypertrophic obstructive cardiomyopathy, prohibitive left ventricular outflow tract calcification, sinus of Valsalva diameter unsuitable for placement of the self-expanding bioprosthesis, aortic annulus diameter of <18 or >30 mm, significant ascending aortopathy, or ascending aorta diameter > 4.5 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year and annually through 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the safety and effectiveness of the Medtronic TAVR system in patients with specific heart valve issues who are low risk for traditional surgery. The device replaces damaged heart valves through a small cut in the leg, avoiding open-heart surgery. This method has shown promise as an alternative to traditional surgery in patients with severe heart valve problems.

Who is the study for?

This trial is for patients with severe aortic stenosis and bicuspid aortic valve disease who are at low risk for surgical valve replacement. Participants must be over 60, have no major health issues like blood disorders or recent heart attacks, and not be pregnant or breastfeeding. They should agree to follow-up visits.

What is being tested?

The Medtronic TAVR system is being tested in this study to see if it's safe and effective for people with bicuspid aortic valves needing valve replacement but considered low-risk for traditional surgery.

What are the potential side effects?

Potential side effects may include reactions to materials used in the TAVR system, bleeding complications due to necessary anticoagulation therapy, infection risks, and possible impact on other heart valves.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart's aortic valve has two flaps and was confirmed by a CT scan.

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I have been diagnosed with severe aortic stenosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart artery blockage.

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My heart does not have specific conditions that would prevent certain treatments.

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I am under 60 years old.

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I am not pregnant, breastfeeding, legally incompetent, or considered vulnerable.

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I do not have blood disorders, ongoing infections, recent strokes, or artery disease in my neck.

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I need emergency surgery.

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I had a heart attack caused by unstable heart arteries within the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year and annually through 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year and annually through 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year and annually through 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy: Percent of Participants Who Meet All Device Success Criteria at 30 Days Post-procedure.

Safety: Percent of Participants With All-Cause Mortality or Disabling Stroke Rate at 30 Days Post-procedure.

Secondary study objectives

All Stroke (Disabling and Non-Disabling) Rate

All-Cause Mortality Rate

Change in Health-related Quality of Life (QoL) as Assessed by Kansas City Cardiomyopathy (KCCQ) Instrument at Baseline and 30 Days

+15 more

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: Medtronic TAVR SystemsExperimental Treatment1 Intervention

Treatment of patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR with Medtronic Evolut PRO and Evolut R systems

0 / 9Eligibility 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

Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive procedure used to treat severe aortic stenosis, including in patients with Bicuspid Aortic Valve (BAV). The mechanism of action involves inserting a catheter through the femoral artery to deliver and implant a new valve within the diseased aortic valve. This new valve takes over the function of regulating blood flow from the heart to the aorta, thereby improving cardiac output and reducing symptoms of aortic stenosis. For BAV patients, TAVR is particularly significant as it offers a less invasive alternative to open-heart surgery, reducing recovery time and associated risks, which is crucial for patients who may be at higher surgical risk due to the unique anatomy of BAV.

[Transcatheter aortic valve replacement : from a concept to a medical revolution].[Interventional catheter treatment of tricuspid valve regurgitation].Percutaneous coronary and structural interventions in women: a position statement from the EAPCI Women Committee.