TAVI vs SAVR for Aortic Stenosis

(SURTAVI Trial)

Recruiting at 86 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

1746 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to investigate the safety and efficacy of transcatheter aortic valve implantation (TAVI) in patients with severe, symptomatic Aortic Stenosis (AS) at intermediate surgical risk by randomizing patients to either Surgical Aortic Valve Replacement (SAVR) or TAVI with the Medtronic CoreValve® System. Single Arm: The purpose of this trial is to evaluate the safety and effectiveness of transcatheter aortic valve implementation (TAVI) in patients with severe symptomatic Aortic Stenosis (AS) at intermediate surgical risk with TAVI. This is a non-randomized phase of the pivotal clinical trial.

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.

What data supports the effectiveness of the treatment Medtronic CoreValve® Evolut R System for aortic stenosis?

Research shows that the Evolut R system, used in transcatheter aortic valve implantation (TAVI), has a favorable safety profile and better heart function compared to traditional surgery (SAVR) for patients with severe aortic stenosis. In a study, TAVI with Evolut R had a lower rate of death or serious stroke at 30 days compared to surgery, suggesting it may be a preferred option for certain patients. ^{1 2 3 4 5}

Is the TAVI procedure with Medtronic CoreValve and Evolut R systems safe for humans?

Studies have shown that the Medtronic CoreValve and Evolut R systems used in TAVI procedures are generally safe for patients with severe aortic stenosis, with safety data collected from various clinical trials and real-world settings. ^{1 3 4 6 7}

How does the TAVI treatment with Medtronic CoreValve® Evolut R System differ from other treatments for aortic stenosis?

The TAVI treatment using the Medtronic CoreValve® Evolut R System is unique because it is a minimally invasive procedure that involves inserting a new valve through a small incision, which is less risky than traditional open-heart surgery (SAVR). It has shown a favorable safety profile and better heart function at 30 days compared to SAVR, making it a preferred option for patients at intermediate surgical risk. ^{1 2 3 8 9}

Research Team

David H. Adams, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Michael J. Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Patrick W. Serruys, MD, PhD

Principal Investigator

National Heart & Lung Institute of Imperial College in London

Nicolas M. Van Mieghem, MD

Principal Investigator

Erasmus Medical Center

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. 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]

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

Propensity-Matched Comparison of Evolut-R Transcatheter Aortic Valve Implantation With Surgery in Intermediate-Risk Patients (from the SURTAVI Trial). [2020]

3. France pubmed.ncbi.nlm.nih.gov

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

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

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

5. 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]

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. 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]

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

The incidence of transcatheter aortic valve implantation-related heart block in self-expandable Medtronic CoreValve and balloon-expandable Edwards valves. [2012]

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

Differences in Outcomes and Indications between Sapien and CoreValve Transcatheter Aortic Valve Implantation Prostheses. [2020]