TAVR Valves for Aortic Valve Stenosis

(SAVE Trial)

Recruiting at 3 trial locations

Overseen By Kacorri, Ardit, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Marvin Eng

Disqualifiers: Pregnancy, Renal dysfunction, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4-6 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

Open-label, prospective randomized comparison of Supra-annular valves (Medtronic Evolut Pro) vs. annular valves (Edwards Sapien Ultra) for small annuli (≤23 mm)

Do I need to stop my current medications for the trial?

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 Edwards Sapien Ultra and Medtronic Evolut Pro for aortic valve stenosis?

Research shows that the Edwards Sapien 3 and Medtronic Evolut valves are effective for treating severe aortic stenosis (narrowing of the heart's aortic valve) in patients who are at high risk for traditional surgery. These treatments have been shown to improve survival and quality of life, with newer versions designed to reduce complications like leaks and strokes. ^{1 2 3 4 5}

Is TAVR safe for humans?

Research shows that the Edwards SAPIEN 3 and Medtronic Evolut valves, used in TAVR procedures, have been developed to improve safety for patients with aortic valve stenosis. Studies have evaluated their safety and clinical performance, indicating they are generally safe for use in humans. ^{1 4 6 7 8}

How is the TAVR treatment for aortic valve stenosis different from other treatments?

The TAVR treatment, using Edwards Sapien Ultra and Medtronic Evolut Pro valves, is unique because it is a minimally invasive procedure that replaces the aortic valve without open-heart surgery. It uses either balloon-expandable or self-expandable valves, which are designed to reduce complications like leaks around the valve and are suitable for patients who are at high risk for traditional surgery. ^{1 4 5 9 10}

Research Team

Marvin Eng, MD

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for individuals with severe aortic valve stenosis and an aortic valve annulus mean diameter of 23 mm or less. They must be symptomatic, meet the criteria for transcatheter aortic valve replacement (TAVR), and have suitable anatomy. Excluded are those who can't consent, are pregnant or planning pregnancy, at risk of coronary obstruction, have certain types of low-flow heart conditions, need other heart procedures, or have poor kidney function not managed by dialysis.

Inclusion Criteria

My heart team has approved me for a valve replacement without open surgery.

I have severe narrowing of my heart's aortic valve causing symptoms.

The width of your aortic valve is less than 23 millimeters.

Exclusion Criteria

I have a specific heart valve condition with reduced blood flow.

Pregnancy or intent on becoming pregnant prior to completion of all protocol follow-up procedures

Subject unable or unwilling to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the Medtronic Evolut Pro Valve or the Edwards Sapien 3 Ultra Valve

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for valve-related dysfunction and other complications

1 year

Treatment Details

Interventions

• Edwards Sapien Ultra
• Medtronic Evolut Pro

Trial Overview The study compares two types of heart valves in patients with small annuli: Supra-annular valves (Medtronic Evolut Pro) versus annular valves (Edwards Sapien Ultra). It's an open-label trial where participants will know which treatment they receive and will be randomly assigned to one of the two options.

Participant Groups

Group I: Supra-Annular transcatheter heart valve Active Control 1 Intervention

Medtronic Evolut Pro Valve implantation

Group II: Annular transcatheter heart valve Active Control 1 Intervention

Edwards Sapien 3 Ultra implantation

Who Is Running the Clinical Trial?

Marvin Eng

Lead Sponsor

Trials

1

Recruited

150+

William Beaumont Hospitals

Collaborator

Trials

153

Recruited

113,000+

Findings from Research

The review highlights the clinical outcomes and design features of two leading transcatheter aortic valve replacement (TAVR) valves, the Edwards SAPIEN S3 and Medtronic Evolut PRO+, comparing their effectiveness in treating aortic stenosis based on multiple trials.

While TAVR technology has significantly improved the management of aortic stenosis, ongoing advancements are needed to enhance safety during surgery and to develop more durable valve options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current and future transcatheter aortic valve replacement valves. Eikelboom, R., Moran, RM., Yan, W., et al.[2023]

The third generation Sapien 3 device for TAVR showed excellent outcomes, with 92.2% of patients experiencing none or trace paravalvular regurgitation, indicating its efficacy in reducing this complication.

While major vascular complications and bleeding were rare, the study noted a 25.5% rate of permanent pacemaker implantation, suggesting a need for further investigation into this issue in larger patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome. Murray, MI., Geis, N., Pleger, ST., et al.[2018]

In a study of 563 patients undergoing transcatheter aortic valve replacement (TAVR) with either balloon-expandable (BE) or self-expandable (SE) valves, the SE valves were associated with a higher risk of ischemic stroke at 30 days (6.0% vs 1.4%), although other outcomes like mortality and readmission rates were similar between the two types.

Midterm outcomes for both BE and SE valves were comparable, suggesting that while SE valves may pose a short-term stroke risk, overall survival and readmission rates do not significantly differ, indicating that patient selection based on clinical factors is important for optimal valve choice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. Habertheuer, A., Gleason, TG., Kilic, A., et al.[2021]

Surgical aortic valve replacement (SAVR) significantly improves survival and quality of life in patients with severe aortic stenosis compared to medical therapy, as shown in the randomized PARTNER Trial.

Transcatheter Aortic Valve Replacement (TAVR) has been successfully performed on 56 patients at Rhode Island Hospital, yielding outcomes comparable to those in the PARTNER Trial, and is being explored for use in intermediate-risk patients with advancements in valve technology aimed at reducing complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement: a review of current indications and outcomes. Prabhu, W., Gordon, PC.[2014]

The CoreValve Evolut R TAVR system demonstrated high safety with no deaths or strokes observed in 60 high-risk patients within 30 days post-procedure, indicating its effectiveness for treating symptomatic aortic valve stenosis.

The device achieved an overall success rate of 78.6% with minimal paravalvular regurgitation (96.6% had mild or less), and successful repositioning was achieved in all cases, highlighting its reliability in clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. Manoharan, G., Walton, AS., Brecker, SJ., et al.[2021]

In a review of 6 studies involving 1,664 patients, both the Edwards SAPIEN S3 (ES3) and Medtronic's Evolut R transcatheter heart valves showed similar safety profiles and procedural success rates, with no significant differences in 30-day mortality, stroke, or major complications.

However, the ES3 group had a higher risk of acute kidney injury, while the Evolut R group had a higher rate of new permanent pacemaker implantation, indicating different safety considerations for each device.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. Li, YM., Tsauo, JY., Liao, YB., et al.[2021]

Transcatheter aortic valve replacement (TAVR) is now a standard treatment for patients with severe aortic stenosis at intermediate risk for surgery, showcasing its growing acceptance in clinical practice.

The Evolut PRO system, a new self-expandable valve from Medtronic, represents significant advancements in TAVR technology, aimed at enhancing device quality and safety compared to earlier models.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves. Mahtta, D., Elgendy, IY., Bavry, AA.[2023]

References

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

Current and future transcatheter aortic valve replacement valves. [2023]

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

Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. [2019]

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

First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. [2021]

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

Transcatheter aortic valve replacement: a review of current indications and outcomes. [2014]

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

Procedural outcomes of the 34 mm EvolutR Transcatheter valve in a real-world population insights from the HORSE multicenter collaborative registry. [2022]

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

Treatment of Symptomatic Severe Aortic Stenosis With a Novel Resheathable Supra-Annular Self-Expanding Transcatheter Aortic Valve System. [2021]

8. China pubmed.ncbi.nlm.nih.gov

Comparison of third generation balloon-expandable Edwards Sapien 3 versus self-expandable Evolut R in transcatheter aortic valve implantation: a meta-analysis. [2021]

9. England pubmed.ncbi.nlm.nih.gov

From CoreValve to Evolut PRO: Reviewing the Journey of Self-Expanding Transcatheter Aortic Valves. [2023]

10. Spain pubmed.ncbi.nlm.nih.gov

Comparison of the Hemodynamic Performance of the Balloon-expandable SAPIEN 3 Versus Self-expandable Evolut R Transcatheter Valve: A Case-matched Study. [2018]