TAVR for Aortic Stenosis

Not currently recruiting at 114 trial locations

Overseen By Hang Nguyen

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Disqualifiers: Age < 65, LVEF ≤ 20%, 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 explores the safety and effectiveness of the Medtronic TAVR System, a transcatheter aortic valve replacement, for individuals with moderate aortic stenosis. This condition narrows the heart's aortic valve, affecting blood flow. The study includes two groups: one receives the TAVR treatment along with regular medical management, while the other receives only regular medical management. Ideal participants have moderate aortic stenosis with noticeable symptoms such as shortness of breath, decreased exercise ability, or recent heart failure. As an unphased trial, this study allows participants to contribute to valuable research that could enhance future treatment options.

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.

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

Research has shown that the Medtronic Evolut PRO+ and Evolut FX TAVR systems are generally safe. One study found these systems have low complication rates, meaning they rarely cause unexpected health problems. Another study demonstrated that patients using the Evolut TAVR systems had survival rates similar to those who underwent surgery, indicating the treatment's reliability.

The Evolut FX TAVR system also showed favorable outcomes with low rates of pacemaker implantation, a positive safety indicator. These systems have received approval for certain uses in Europe, further supporting their safety.

While both systems have shown good safety results, every treatment carries some risks. Consult your doctor to determine if it's the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Evolut FX and Evolut PRO+ TAVR systems for treating aortic stenosis because they offer a minimally invasive alternative to traditional surgical valve replacement. Unlike standard open-heart surgery, these TAVR systems are delivered via a catheter, which can mean a shorter recovery time and less risk for patients. Additionally, the Evolut systems are designed to accommodate a wider range of patient anatomies, potentially increasing their suitability for diverse patient populations. These innovative features could significantly improve patient outcomes and expand treatment options for those with aortic stenosis.

What evidence suggests that the Medtronic TAVR System could be effective for aortic stenosis?

Research has shown that the Medtronic Evolut FX TAVR System effectively treats aortic stenosis, a narrowing of the heart's aortic valve. Studies have found that patients using this system experience good valve function and few complications over five years. In this trial, participants may receive either the Evolut FX TAVR System or the Evolut PRO+ TAVR System. Early results indicate that the Evolut PRO+ TAVR System is safe and effective for those with severe aortic stenosis. Both systems have demonstrated excellent valve performance and minimal leakage around the valve. Overall, these treatment options offer promising results for people with aortic stenosis. ^{2 3 6 7 8}

Who Is on the Research Team?

Paul Sorajja, MD

Principal Investigator

Allina Health System

Josep Rodes-Cabau, MD

Principal Investigator

Fondation IUCPQ

Stephan Windecker, MD

Principal Investigator

Inselspital, Universitätsspital Bern

Are You a Good Fit for This Trial?

This trial is for adults over 65 with moderate, symptomatic aortic stenosis (AS) who have specific heart function measurements and are suitable for the Medtronic TAVR System via transfemoral access. Excluded are those needing cardiac surgery, with certain types of bicuspid aortic valves or severe heart issues like low ejection fraction or cardiac amyloidosis.

Inclusion Criteria

I have symptoms of aortic stenosis or my physical ability is below normal levels.

My heart valve is moderately narrowed.

You have had a heart failure event or hospitalization within the past year, certain heart-related test results are abnormal, or you have specific heart conditions that make you unsuitable for the study.

Exclusion Criteria

I have been diagnosed with cardiac amyloidosis.

I need and am a candidate for a procedure to improve blood flow to my heart.

Your heart's pumping ability is very weak, as shown by a heart ultrasound test.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either the Evolut PRO+ TAVR System, Evolut FX System, or guideline-directed management and therapy (GDMT) alone

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Evolut FX TAVR System
• Medtronic Evolut PRO+ TAVR System

Trial Overview The trial tests the safety and effectiveness of two Medtronic TAVR systems in expanding treatment to patients with moderate AS. Participants will receive either the Evolut PRO+ or FX system along with standard heart management therapies.

How Is the Trial Designed?

Group I: Medtronic Evolut PRO+, or Evolut FX,TAVR System, & guideline-directed management & therapy (GDMT) Experimental Treatment 1 Intervention

Medtronic Evolut PRO+ TAVR or Evolut FX TAVR Systems, \& guideline-directed management \& therapy

Group II: Clinical site determined guideline-directed management and therapy (GDMT) alone Active Control 1 Intervention

Clinical site determined guideline-directed management and therapy (GDMT) alone

Evolut FX TAVR System is already approved in United States for the following indications:

Approved in United States as Evolut FX TAVR System for:

• Symptomatic severe aortic stenosis across all risk categories (extreme, high, intermediate, and low)

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

Published Research Related to This Trial

In a study of 12,294 patients, the new-generation Evolut R transcatheter aortic valve replacement (TAVR) showed a higher device success rate (96.6%) compared to the first-generation Medtronic CoreValve (94.8%), indicating better overall performance.

Evolut R also significantly reduced the risk of complications such as moderate-to-severe paravalvular leak, myocardial injury, and the need for permanent pacemaker implantation, leading to a 40% reduction in 30-day all-cause mortality compared to CoreValve.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcathether aortic valve implantation with the new repositionable self-expandable Medtronic Evolut R vs. CoreValve system: evidence on the benefit of a meta-analytical approach. Kowalewski, M., Gozdek, M., Raffa, GM., et al.[2019]

In a study of 226 patients undergoing TAVR with the Evolut FX system, the device showed favorable 30-day outcomes, including a low rate of paravalvular leaks (14.3% mild, 0.9% moderate) and high rates of successful commissural alignment (96.5%).

The Evolut FX system outperformed the previous PRO+ model by achieving more symmetrical implantations, fewer device recaptures (26.1% vs 39.5%), and improved commissural alignment, suggesting it may be particularly beneficial for younger patients requiring long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System. Zaid, S., Attizzani, GF., Krishnamoorthy, P., et al.[2023]

The FORWARD study, involving 1,040 patients aged around 81 years, showed that the Evolut R transcatheter heart valve replacement (TAVR) had a low 1-year all-cause mortality rate of 8.9% and a cardiovascular mortality rate of 6.9%, indicating good safety outcomes.

At 1 year, the study reported a very low incidence of disabling stroke (2.1%) and significant paravalvular leak (1.2%), demonstrating the efficacy of the Evolut R device in routine clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. Manoharan, G., Van Mieghem, NM., Windecker, S., et al.[2019]

The CoreValve Evolut R and PRO devices demonstrated good clinical safety and effective hemodynamic outcomes in patients with severely calcified aortic valve anatomy, despite these patients being older and having smaller aortic valve areas.

Patients with severely calcified anatomy required more pre-dilatation and had a higher rate of permanent pacemaker implantation (32.9% vs 8.8% in non-severely calcified patients), indicating a need for careful management in this subgroup.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis. Piayda, K., Hellhammer, K., Veulemans, V., et al.[2021]

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]

The Evolut-R transcatheter aortic valve implantation (TAVI) system shows comparable safety and efficacy to the first-generation CoreValve, with a high implantation success rate of 99% for Evolut-R versus 94% for CoreValve.

While there were no significant differences in major complications or adverse events between the two devices, the Evolut-R demonstrated a numerically lower combined endpoint rate (24% vs. 37% for CoreValve), suggesting potential advantages that warrant further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative Matched Outcome of Evolut-R vs CoreValve Transcatheter Aortic Valve Implantation. Landes, U., Bental, T., Barsheshet, A., et al.[2017]

In a study involving 995 patients, the new-generation Medtronic Evolut R prosthesis demonstrated a shorter procedure time and lower use of predilatation and contrast dye compared to the older CoreValve, indicating improved efficiency in the TAVI procedure.

Thirty-day clinical outcomes, including rates of complications and mortality, were similar between the Evolut R and CoreValve, suggesting that the new device is as safe and effective as its predecessor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. Noble, S., Stortecky, S., Heg, D., et al.[2020]

Citations

1. news.medtronic.com news.medtronic.com/2025-03-30-Medtronic-Evolut-TM-TAVR-system-shows-durable-clinical-outcomes-and-outstanding-valve-performance-at-five-years-in-low-risk-aortic-stenosis-patients

Medtronic Evolut™ TAVR system shows durable clinical ... Patients with severe aortic stenosis who were treated with either Evolut TAVR or surgery showed comparable rates of all-cause mortality or ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936879825017315

30-Day and 1-Year Outcomes From the Optimize PRO ... The Optimize PRO FX Addendum study produced favorable outcomes, including low PPI rates, with the Evolut FX TAV system and demonstrated high ...

3. massdevice.com massdevice.com/medtronic-evolut-tavr-shows-durable-five-year-outcomes-in-low-risk-patients/

Medtronic says Evolut TAVR shows durable five-year ... Medtronic says its Evolut TAVR shows strong valve performance and durable outcomes at 5 years in low-risk aortic stenosis patients.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37438029/

First-in-Human Multicenter Experience of the Newest ... The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device ...

5. jacc.org jacc.org/doi/10.1016/j.jcin.2023.05.004

First-in-Human Multicenter Experience of the Newest ... The Evolut FX system demonstrated favorable 30-day outcomes with a significant improvement over PRO+ in achieving commissural alignment, fewer device recaptures ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130021S174B.pdf

summary of safety and effectiveness data (ssed) The Medtronic Evolut PRO+ and Evolut FX systems are currently approved for the redo. TAVR indication in 27 member states of the European Union ( ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02701283

NCT02701283 | Medtronic Evolut Transcatheter Aortic ... The study objective is to demonstrate that the safety and effectiveness of the Medtronic TAVR system as measured by rates of all-cause mortality or ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553838923006279

Early experience with the Evolut FX self-expanding valve ... The Evolut FX THV performed well when used for patients with severe aortic stenosis, demonstrating high success with low complication rates.