TAVR vs SAVR for Aortic Valve Stenosis

Not currently recruiting at 94 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Must not be taking: Aspirin, Heparin, Clopidogrel, others

Disqualifiers: Sepsis, Dementia, Pregnancy, others

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

Compensation: Varies

Number of Visits: 60

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for severe aortic stenosis, a condition where the heart's aortic valve narrows, hindering blood flow. One group will undergo the traditional surgical approach (SAVR), while the other will receive a less invasive procedure using the Medtronic Evolut Transcatheter Aortic Valve Replacement (TAVR) system. The researchers aim to determine if the TAVR system is as safe and effective as the surgical method in terms of survival and preventing major strokes after two years. Individuals diagnosed with severe aortic stenosis and considered low-risk for surgery might be suitable candidates for this trial. As an unphased trial, it offers patients the chance to contribute to research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known hypersensitivity to certain medications like aspirin, heparin, or clopidogrel, this might affect your eligibility.

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

Studies have shown that the Medtronic Evolut Transcatheter Aortic Valve Replacement (TAVR) system is generally safe for patients with severe aortic stenosis, a condition where the heart's valve narrows excessively. Research indicates that the Evolut TAVR system maintains a good safety record, with very low death rates one year post-procedure. Patients in these studies experienced positive immediate results and improved heart function over time. Overall, the TAVR system is well-tolerated, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcatheter Aortic Valve Replacement (TAVR) because it offers a less invasive alternative to traditional Surgical Aortic Valve Replacement (SAVR) for treating aortic valve stenosis. Unlike SAVR, which requires open-heart surgery, TAVR involves threading a catheter through a blood vessel to implant a new valve, which can mean a quicker recovery and less risk for patients who aren't ideal candidates for surgery. The Medtronic Evolut TAVR system specifically features a self-expanding valve design, which allows for a more precise fit and potentially better outcomes.

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

This trial will compare the Medtronic Evolut Transcatheter Aortic Valve Replacement (TAVR) with Surgical Aortic Valve Replacement (SAVR) for treating severe aortic stenosis. Research has shown that TAVR is effective, with studies finding similar survival and stroke rates for TAVR patients and those undergoing traditional surgery over five years. TAVR also outperformed surgery, with fewer serious issues between the valve and patient. After one year, major complications were slightly less common with TAVR compared to surgery. These findings suggest that TAVR is a reliable and long-lasting option for people with low-risk severe aortic stenosis. ^{2 3 6 7 8}

Who Is on the Research Team?

John Forrest

Principal Investigator

Yale New Haven Hospital

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for people with severe aortic stenosis who are considered low risk for surgical valve replacement. They must meet specific heart criteria, agree to follow-up visits, and not have conditions that conflict with the treatment like blood disorders or recent major health events.

Inclusion Criteria

Documented heart team agreement of low risk for SAVR

Subject and treating physician agreement to return for all required post-procedure follow-up visits

I have severe narrowing of the heart's aortic valve.

Exclusion Criteria

I do not have blood disorders, ongoing severe infections, recent strokes, or symptomatic artery disease in my neck.

I am not pregnant, in another drug trial, needing emergency surgery, or recently had a heart attack.

I have a serious heart condition or an unsuitable heart structure for certain treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Treatment

Subjects are randomized to either TAVR with the Medtronic TAVR system or to SAVR.

Procedure and immediate recovery

Pre-procedure, post-procedure, and discharge visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

30 days, 6 months, 1 year, 18 months, and annually through 10 years

Continued Access Phase

Non-randomized continued access trial where all subjects receive TAVR with the Medtronic TAVR system.

Procedure and immediate recovery

Pre-procedure, post-procedure, discharge, 30 days, and annually through 10 years

What Are the Treatments Tested in This Trial?

Interventions

• Medtronic Evolut Transcatheter Aortic Valve Replacement
• Surgical Aortic Valve Replacement (SAVR)

Trial Overview The study compares the Medtronic TAVR system's safety and effectiveness against traditional surgery in treating severe aortic stenosis at two years. It includes an initial randomized phase followed by a single-arm continued access phase.

How Is the Trial Designed?

Group I: Medtronic Transcatheter Aortic Valve Replacement Systems Experimental Treatment 1 Intervention

Treatment of Aortic Stenosis with the Medtronic CoreValve System Transcatheter Aortic Valve Implantation (TAVI) device or the Medtronic Corevalve Evolut R System Transcatheter Aortic Valve Implantation (TAVI)

Group II: Surgical Aortic Valve Replacement (SAVR) Active Control 1 Intervention

Treatment of Aortic Stenosis with commercial 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

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]

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. 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. medtronic.com medtronic.com/en-us/healthcare-professionals/specialties/interventional-cardiology/therapies-procedures/transcatheter-aortic-valve-replacement/clinical-evidence/key-studies.html

Key Studies - Transcatheter Aortic Valve Replacement CoreValve™/Evolut™ TAVR had significantly better valve performance than surgery as assessed by BVD at 5 years,§ with three times lower severe prosthesis-patient ...

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

NCT02746809 | Medtronic CoreValve Evolut R U.S. ... The study objectives are to assess the safety and efficacy of the CoreValve Evolut 34R transcatheter aortic valve replacement (TAVR) system in patients with ...

5. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2019/03/15/18/34/EVOLUT-Low-Risk

Evolut Surgical Replacement and Transcatheter Aortic ... Principal Findings: · Primary endpoint at 1 year: 2.9% for TAVR vs. 4.6% for SAVR (p > 0.05) · Mean aortic gradient at 1 year: 8.6 mm Hg for TAVR ...

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

summary of safety and effectiveness data - accessdata.fda.gov The applicant performed a clinical study to establish a reasonable assurance of safety and effectiveness of TAVR with the Medtronic CoreValve System and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6046659/

Transcatheter aortic valve replacement with the 34 mm ... The 34 mm Evolut system has shown satisfactory acute clinical and haemodynamic results in the treatment of patients with severe aortic stenosis.

8. sciencedirect.com sciencedirect.com/science/article/pii/S1936879818316212

1-Year Outcomes With the Evolut R Self-Expanding ... The FORWARD study demonstrated good safety and efficacy profiles for the next-generation Evolut R THV up to 1-year follow-up, with very low mortality and ...