TAVR for Bicuspid Aortic Valve Disease

Recruiting at 26 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Must not be taking: Aspirin, Heparin, Ticlopidine, others

Disqualifiers: Age <60, Severe dementia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 31

Duration: 1 week

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Medtronic TAVR Systems for Bicuspid Aortic Valve Disease?

Studies show that transcatheter aortic valve replacement (TAVR) using new-generation devices, like those from Medtronic, has favorable early outcomes for patients with bicuspid aortic valve stenosis, indicating it can be an effective treatment option. ^{1 2 3 4 5}

How is the TAVR treatment different for bicuspid aortic valve disease?

TAVR (transcatheter aortic valve replacement) is a less invasive alternative to traditional open-heart surgery for replacing the aortic valve, especially in patients with bicuspid aortic valve disease. Unlike surgical aortic valve replacement, TAVR is performed through a catheter, which means it can be done without opening the chest, potentially leading to quicker recovery times. ^{1 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

Basel Ramlawi, MD

Principal Investigator

Paramount Heart

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

John Forrest, MD

Principal Investigator

Yale University

Eligibility Criteria

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.

Inclusion Criteria

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

Subject and treating physician agreement for all required post-procedure follow-up visits

I have been diagnosed with severe aortic stenosis.

Exclusion Criteria

You have a medical condition that makes it unsafe to have a bioprosthetic valve placed.

I have severe heart artery blockage.

You have severe heart-related shock, ongoing stomach bleeding, refuse to get a blood transfusion, have severe memory loss, or are expected to live less than 2 years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

All subjects will be treated with a Medtronic TAVR system

1 week

1 visit (in-person) for the procedure

Initial Follow-up

Participants are monitored for safety and effectiveness post-procedure

30 days

Visits at discharge, 30 days post-procedure

Long-term Follow-up

Participants are monitored annually for safety and effectiveness

10 years

Annual visits

Treatment Details

Interventions

• Medtronic TAVR Systems

Trial Overview 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.

Participant Groups

Group I: Medtronic TAVR Systems Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Medtronic Cardiovascular

Lead Sponsor

Trials

78

Recruited

37,300+

Geoff Martha

Medtronic Cardiovascular

Chief Executive Officer since 2020

Finance degree from Penn State University

Dr. Kendra J. Grubb

Medtronic Cardiovascular

Chief Medical Officer

MD from Emory University

Findings from Research

Only 6.8% of patients with bicuspid aortic valve (BAV) disease underwent transcatheter aortic valve replacement (TAVR), and while TAVR showed higher initial hospitalization mortality compared to surgical aortic valve replacement (SAVR), risk-adjusted analyses indicated no significant difference in overall mortality between the two procedures.

Patients undergoing TAVR had higher rates of pacemaker implantation and reintervention compared to those receiving SAVR, suggesting that while TAVR can be a viable option, careful patient selection is crucial due to the potential for complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Stenosis. Sanaiha, Y., Hadaya, JE., Tran, Z., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement in bicuspid aortic valve disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Comparison of Self-Expanding and Mechanically Expanded Transcatheter Aortic Valve Prostheses. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Bicuspid Aortic Valve Stenosis: Favorable Early Outcomes With a Next-Generation Transcatheter Heart Valve in a Multicenter Study. [2022]

4. China pubmed.ncbi.nlm.nih.gov

Clinical outcomes and prognostic factors of transcatheter aortic valve implantation in bicuspid aortic valve patients. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Transcatheter Aortic Valve Replacement With the Latest-Iteration Self-Expanding or Balloon-Expandable Valves: The Multicenter OPERA-TAVI Registry. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of Bicuspid Aortic Valve Stenosis Using Transcatheter Heart Valves. [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Transcatheter and Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valve Stenosis. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

The bicuspid aortic valve: Still a toothy problem. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Outcomes in Transcatheter Aortic Valve Replacement for Bicuspid Versus Tricuspid Aortic Valve Stenosis. [2022]