TAVR Valves for Aortic Valve Stenosis

(SAVE Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two types of heart valves to determine which performs better for individuals with severe aortic valve stenosis, a condition where the heart’s aortic valve narrows, hindering blood flow. The trial examines the Medtronic Evolut Pro and the Edwards Sapien Ultra valves. Individuals advised to undergo transcatheter aortic valve replacement (TAVR) with a small valve opening (23 mm or less) may be suitable candidates. The goal is to identify which valve enhances patient well-being and heart function. As an unphased trial, this study allows patients to contribute to significant research that could advance future heart valve treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the Edwards Sapien Ultra valve is generally well-accepted by patients. In past studies, patients experienced fewer leaks around the valve without an increase in death rates. This valve is already approved for treating heart disease, indicating it meets safety standards.

For the Medtronic Evolut Pro valve, early results indicate safety. One study found that just over 3% of patients had major complications in the first month, which is considered low. Additionally, long-term data show it is as safe as traditional surgery.

Both treatments have undergone thorough study and are usually well-tolerated with manageable risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Edwards Sapien 3 Ultra and Medtronic Evolut Pro valves because they offer innovative approaches to treating aortic valve stenosis. Unlike traditional surgical valve replacement, these transcatheter heart valves are implanted through a minimally invasive procedure, which can be a game-changer for patients who are at high risk for surgery. The Edwards Sapien 3 Ultra focuses on annular valve implantation, while the Medtronic Evolut Pro offers a supra-annular approach, potentially providing more effective outcomes depending on the patient's anatomy. These features might lead to faster recovery times and improved quality of life compared to conventional surgical options.

What evidence suggests that this trial's treatments could be effective for aortic valve stenosis?

In this trial, participants will receive one of two different transcatheter heart valves for aortic stenosis. Research has shown that the Edwards Sapien 3 Ultra valve, one of the options in this trial, performs well for individuals with aortic stenosis, a condition where the heart valve narrows. Studies found it was successfully implanted in all cases and functioned well in 97.8% of them, with very few leaks. Patients experienced improved blood flow, indicating effective valve function.

Similarly, the Medtronic Evolut Pro valve, another option in this trial, has demonstrated long-term effectiveness for aortic stenosis. After five years, it showed lasting benefits and a lower risk of serious bleeding compared to other valves. Most patients experienced little to no leakage, indicating the valve's effectiveness.

Both valves have been shown to improve heart function and reduce symptoms in patients with aortic stenosis. ^{6 7 8 9 10}

Who Is on the Research Team?

Marvin Eng, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

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.

Subject unable or unwilling to provide informed consent

I am scheduled for a heart procedure like valve repair or appendage closure.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. edwards.com edwards.com/newsroom/news/2025-10-27-edwards-sapien-3-tavr-delivers-proven-long-term-be

Edwards SAPIEN 3 TAVR Delivers Proven Long-term ... The data, which showed superior clinical outcomes at one year, also demonstrate excellent long-term valve performance and durability. Separately ...

2. jacc.org jacc.org/doi/10.1016/j.jcin.2024.02.015

Real-World Outcomes for the Fifth-Generation Balloon ... At discharge, S3UR patients exhibited significantly lower mean gradients (9.2 ± 4.6 mm Hg vs 12.0 ± 5.7 mm Hg; P < 0.0001) and larger aortic ...

3. eurointervention.pcronline.com eurointervention.pcronline.com/article/sapien-3-ultra-balloon-expandable-transcatheter-aortic-valve-in-hospital-and-30-day-results-from-the-multicentre-s3u-registry

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra ... Implant success was 100%, and device success according to the VARC-2 definition was 97.8%; there were two cases (1.4%) with moderate paravalvular leak (PVL), ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9988804/

Cost-Effectiveness of SAPIEN 3 Transcatheter Aortic Valve ... TAVI with SAPIEN 3 appears to be a clinically meaningful, cost-effective treatment option over SAVR for patients with severe symptomatic aortic stenosis and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1936879824004618

Real-World Outcomes for the Fifth-Generation Balloon ... The aim of this study was to compare S3UR to S3/S3U for procedural, in-hospital, and 30-day clinical and echocardiographic outcomes after ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S112B.pdf

FDA - Summary of Safety and Effectiveness Data The Edwards SAPIEN 3 and SAPIEN 3 Ultra THV System is indicated for patients with symptomatic heart disease due to failing (stenosed, insufficient, or combined) ...

7. edwards.com edwards.com/healthcare-professionals/products-services/transcatheter-heart/transcatheter-sapien-3-ultra

Transcatheter SAPIEN 3 Ultra A prospective multi center study of the SAPIEN 3 Ultra system in intermediate-risk patients with severe aortic stenosis. Presented at: PCR London Valves 2019; ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03471065

The SAPIEN 3 Ultra System in Intermediate Risk Patients ... This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140031S162B.pdf

Summary of Safety and Effectiveness Data (SSED) However, the results obtained on the Edwards SAPIEN 3 and SAPIEN 3 Ultra THV Systems are considered applicable to the Edwards SAPIEN 3 Ultra RESILIA THV System ...

10. eurointervention.pcronline.com eurointervention.pcronline.com/article/one-year-outcomes-after-transcatheter-aortic-valve-implantation-with-the-latest-generation-sapien-balloon-expandable-valve-the-s3u-registry

One-year outcomes after transcatheter aortic valve ... A study comparing 1-year outcomes of TAVI using the SAPIEN 3 Ultra vs SAPIEN 3 valves found the S3U reduced paravalvular leak rates without affecting death, ...