TAVR for Aortic Stenosis

Recruiting at 105 trial locations

Overseen By Hang Nguyen

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medtronic Cardiovascular

Disqualifiers: Age < 65, LVEF ≤ 20%, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

Obtain safety and effectiveness data to support indication expansion for the Medtronic TAVR System to include patients with moderate, AS.

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 Evolut FX TAVR System for Aortic Stenosis?

The Evolut FX TAVR System is based on previous successful systems like the CoreValve and Evolut R, which have shown excellent results in treating aortic stenosis, especially in patients with challenging conditions like severely calcified aortic valves. ^{1 2 3 4 5}

Is the TAVR procedure using the Evolut systems generally safe for humans?

Research on the Evolut R and PRO TAVR systems shows they are generally safe for treating aortic stenosis, with studies reporting positive safety outcomes in high-risk patients. The Evolut FX system is newer, and while early reports are limited, it is designed to improve upon previous versions. ^{1 4 5 6 7}

How is the Evolut FX TAVR System treatment different from other treatments for aortic stenosis?

The Evolut FX TAVR System is unique because it is a self-expanding valve that can be repositioned during the procedure, which may offer better placement accuracy compared to older systems. This system is designed for patients at high or extreme risk for traditional surgery, providing a less invasive option for treating aortic stenosis. ^{1 2 3 4 5}

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

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Evolut FX TAVR System (Transcatheter Aortic Valve Replacement (TAVR))
• Medtronic Evolut PRO+ TAVR System (Transcatheter Aortic Valve Replacement (TAVR))

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.

Participant Groups

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

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

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 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 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]

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 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]

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]

References

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

First-in-Human Multicenter Experience of the Newest Generation Supra-Annular Self-Expanding Evolut FX TAVR System. [2023]

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

Comparative Matched Outcome of Evolut-R vs CoreValve Transcatheter Aortic Valve Implantation. [2017]

3. United States 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. [2019]

4. Australia pubmed.ncbi.nlm.nih.gov

Performance of the CoreValve Evolut R and PRO in Severely Calcified Anatomy: A Propensity Score Matched Analysis. [2021]

5. 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]

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

1-Year Outcomes With the Evolut R Self-Expanding Transcatheter Aortic Valve: From the International FORWARD Study. [2019]

7. France pubmed.ncbi.nlm.nih.gov

Comparison of procedural and clinical outcomes with Evolut R versus Medtronic CoreValve: a Swiss TAVI registry analysis. [2020]