TAVR vs SAVR for Aortic Valve Stenosis

Recruiting at 90 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

2223 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Medtronic Evolut Transcatheter Aortic Valve Replacement for aortic valve stenosis?

Research shows that the Medtronic Evolut Transcatheter Aortic Valve Replacement (TAVR) is as effective as traditional surgery (SAVR) for patients with severe aortic stenosis, especially those at low surgical risk. In studies, TAVR had similar rates of survival and stroke compared to surgery, and it also improved quality of life and reduced complications like atrial fibrillation and kidney injury. ^{1 2 3 4 5}

Is TAVR safe compared to SAVR for treating aortic valve stenosis?

Research shows that TAVR (Transcatheter Aortic Valve Replacement) is generally safe and has similar safety outcomes to SAVR (Surgical Aortic Valve Replacement) for patients with aortic valve stenosis, including those at low surgical risk. Studies found that the risk of death or disabling stroke at 2 years was similar between TAVR and SAVR, indicating that TAVR is a safe alternative. ^{1 2 4 6 7}

How does the TAVR treatment differ from SAVR for aortic valve stenosis?

TAVR (Transcatheter Aortic Valve Replacement) is a less invasive treatment compared to SAVR (Surgical Aortic Valve Replacement) because it involves inserting a new valve through a small incision, often in the leg, rather than open-heart surgery. This makes TAVR a suitable option for patients who are at high risk for surgery, and recent studies suggest it may also be effective for those at low surgical risk. ^{1 2 3 8 9}

What is the purpose of this trial?

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 disabling stroke at two years is noninferior to SAVR in the treatment of severe aortic stenosis in subjects who have a low predicted risk of operative mortality for SAVR. The purpose of the expanded use addendum to the Medtronic TAVR in Low Risk Patients Trial protocol is to conclude the randomized phase of the trial and initiate the single-arm, non-randomized, continued access phase of the trial.

Research Team

John Forrest

Principal Investigator

Yale New Haven Hospital

Michael Reardon, MD

Principal Investigator

The Methodist Hospital Research Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

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 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]

References

1. China pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement in low risk patients: a review of PARTNER 3 and Evolut low risk trials. [2020]

2. 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]

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

The Role of Transcatheter Aortic Valve Replacement in Asymptomatic Aortic Stenosis: A Feasibility Analysis. [2022]

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

2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. [2022]

5. India pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement in low-risk patients: superiority or shifting goalposts and statistical crystal-gazing? [2020]

6. 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]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of Current-Generation Transfemoral Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Replacement. [2021]

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

Evolving trends in aortic valve replacement: A statewide experience. [2022]

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

Transcatheter Aortic Valve Replacement Versus Surgical Valve Replacement in Low-Intermediate Surgical Risk Patients: A Systematic Review and Meta-Analysis. [2022]