TAVI vs SAVR for Aortic Stenosis

(SURTAVI Trial)

Not currently recruiting at 88 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Sepsis, Dementia, Renal disease, others

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

Compensation: Varies

Number of Visits: 30

Duration: Expected average of 7 days from admission to discharge

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two treatments for severe aortic stenosis, a heart valve issue causing chest pain and breathlessness, in patients with moderate surgical risk. One group will receive a newer, less invasive treatment called transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve® Evolut R System. The other group will undergo traditional open-heart surgery, known as surgical aortic valve replacement (SAVR). The trial aims to determine which method is safer and more effective. Patients with symptoms from aortic stenosis, assessed by a heart team as having intermediate surgical risk, are encouraged to consider joining. As an unphased trial, this study allows patients to contribute to important research comparing two established treatment methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you have a known hypersensitivity or contraindication to anticoagulation/antiplatelet regimens, you may not be eligible to participate.

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

Research has shown that the Medtronic CoreValve System, used in TAVI (a less invasive procedure to replace a heart valve), is generally well-tolerated by patients with severe aortic stenosis, a condition where the heart valve doesn't open properly. Studies have found that patients using this system experience similar survival and stroke rates over five years compared to those undergoing traditional open-heart surgery for valve replacement. This suggests the treatment is reasonably safe.

The FDA has approved the Medtronic CoreValve System for treating aortic stenosis, which adds to its safety assurance. However, like any medical procedure, risks and side effects may occur. Patients considering joining a clinical trial should discuss these with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about transcatheter aortic valve implantation (TAVI) using the Medtronic CoreValve® System because it offers a less invasive alternative to the traditional surgical aortic valve replacement (SAVR) for treating aortic stenosis. Unlike SAVR, which requires open-heart surgery, TAVI is performed via catheter, which can mean a shorter recovery time and less risk for patients, particularly those who are older or have other health issues. This system is designed for precision and easier placement, potentially improving outcomes and making the procedure accessible to a broader range of patients who might not be candidates for open surgery.

What evidence suggests that this trial's treatments could be effective for Aortic Stenosis?

This trial will compare the Medtronic CoreValve System used in Transcatheter Aortic Valve Implantation (TAVI) with Surgical Aortic Valve Replacement (SAVR) for individuals with severe narrowing of the heart valve. Research has shown that the Medtronic CoreValve System effectively treats this condition. Studies have found that TAVI and traditional surgical valve replacement yield similar survival and stroke rates over five years. The Medtronic TAVI system is recognized for its reliable performance and positive patient outcomes. The newer Evolut R version of the CoreValve, also studied in this trial, demonstrated better procedural results compared to older versions. Overall, TAVI offers a promising option for those at moderate surgical risk, providing safety and effectiveness comparable to surgery. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael J. Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

David H. Adams, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Nicolas M. Van Mieghem, MD

Principal Investigator

Erasmus Medical Center

Patrick W. Serruys, MD, PhD

Principal Investigator

National Heart & Lung Institute of Imperial College in London

Rüdiger Lange, MD, PhD

Principal Investigator

Deutsches Herzzentrum München

Thomas Walther, MD, PhD

Principal Investigator

Kerckhoff Klinik

Stephan Windecker, MD, PhD

Principal Investigator

Bern University Hospital

Are You a Good Fit for This Trial?

This trial is for people with severe, symptomatic Aortic Stenosis who are at intermediate risk for surgery. They must be of legal age to consent and have a predicted surgical mortality risk between ≥3% and <15%. Participants should commit to follow-up visits, not have had recent strokes or heart attacks, no severe lung disease (COPD), uncontrolled atrial fibrillation, or conditions that prevent anticoagulation.

Inclusion Criteria

I have severe narrowing of my heart's aortic valve with specific measurements.

You have other health problems that make the surgery risk between 3% and 15% at 30 days according to the Heart Team.

I am old enough to make my own medical decisions according to local laws.

Exclusion Criteria

I have severe liver failure.

My lung blood pressure is high.

I am considered frail based on my age, mobility, living situation, weight, grip strength, daily activity ability, and protein levels.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either Surgical Aortic Valve Replacement (SAVR) or Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve® System

Expected average of 7 days from admission to discharge

In-hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at multiple time points

24 months

Visits at 30 days, 6 months, 12 months, 18 months, and 24 months

Long-term follow-up

Participants continue to be monitored for long-term outcomes and safety

3-5 years

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic CoreValve® Evolut R System
• Medtronic CoreValve® System
• Surgical Aortic Valve Replacement (SAVR)

Trial Overview The study compares the safety and effectiveness of two treatments: TAVI using Medtronic CoreValve® Systems versus traditional Surgical Aortic Valve Replacement (SAVR). Patients will either be randomly assigned to one of these treatments or receive TAVI in a non-randomized phase.

How Is the Trial Designed?

Group I: Medtronic CoreValve® System TAVI Experimental Treatment 2 Interventions

Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)

Group II: SAVR Active Control 1 Intervention

Surgical Aortic Valve Replacement (SAVR)

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

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 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]

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 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 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]

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 ... Medtronic Evolut™ TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2025.03.004

5-Year Outcomes After Transcatheter or Surgical Aortic ... At 5 years, patients with severe aortic stenosis who were treated with either TAVR or surgery had comparable rates of all-cause mortality or disabling stroke.

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/p130021s033b.pdf

summary of safety and effectiveness data - accessdata.fda.gov effectiveness of TAVR with the Medtronic CoreValve System and CoreValve Evolut R. System for patients with symptomatic severe native calcific aortic stenosis ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02746809

NCT02746809 | Medtronic CoreValve Evolut R U.S. ... Procedural and 30 day safety and efficacy results from this study will be compared to appropriate historical control data for the Medtronic CoreValve System.

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/comparison-of-procedural-and-clinical-outcomes-with-evolut-r-versus-medtronic-corevalve-a-swiss-tavi-registry-analysis

Comparison of procedural and clinical outcomes with ... In our study, we observed a significantly lower rate of predilatation among patients treated with the Evolut R compared to the CoreValve (44.5% vs. 71.8%), ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01586910

NCT01586910 | Safety and Efficacy Study of the Medtronic ... Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/P130021S058d.pdf

CoreValve™ Evolut™ R System The Medtronic CoreValve™ Evolut™ R system is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native ...