Transcatheter Aortic Valve Replacement for Aortic Stenosis

(RESTORE Trial)

Recruiting at 58 trial locations

Overseen By RESTORE Study Clinical Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medtronic Cardiovascular

Disqualifiers: Paravalvular regurgitation, Endocarditis, Thrombosis, others

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

Compensation: Varies

Number of Visits: 30

Duration: Up to 7 days

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of replacing a failed heart valve using a procedure called redo Transcatheter Aortic Valve Replacement (TAVR). It targets individuals who previously underwent TAVR with a Medtronic or Edwards valve that now requires replacement. Those who have had a TAVR and are experiencing issues with their current valve may qualify for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, providing an opportunity to contribute to significant medical advancements.

Do I need to stop my current medications for this trial?

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.

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

Research has shown that both the Medtronic and Edwards transcatheter aortic valves (TAV) used for treating aortic valve issues are safe. Studies on the Medtronic TAV indicate it is well-tolerated by patients with low risk, with lasting results over five years. The death rate from any cause after five years was similar to those who underwent traditional surgery, indicating no major safety differences.

The Edwards TAV has also proven to be very safe in various studies. Specifically, the SAPIEN 3 valve, part of the Edwards line, achieved a 98% success rate in procedures. Reports from hospitals showed no deaths or strokes, which are important safety measures. Additionally, long-term data over five years demonstrated that the valve maintained its structure and performance well.

These findings suggest that both Medtronic and Edwards TAV systems are generally safe and well-tolerated for patients needing aortic valve replacement. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about redo transcatheter aortic valve replacement (TAVR) for failed transcatheter aortic valves because it offers a potential solution for patients whose initial valve replacements are no longer functioning well. Unlike traditional surgical valve replacement, which involves more invasive open-heart surgery, redo TAVR is minimally invasive, potentially reducing recovery time and associated risks. Additionally, this procedure uses advanced valve technologies from Medtronic and Edwards, which are designed to fit seamlessly into the existing valve structure, offering a promising alternative for those who might not be candidates for another surgery.

What evidence suggests that this trial's treatments could be effective for redo TAVR?

This trial will compare the effectiveness of Medtronic Transcatheter Aortic Valves (TAV) and Edwards Transcatheter Aortic Valves (TAV) in treating aortic stenosis. Studies have shown that both Medtronic and Edwards heart valves effectively treat this condition. Research indicates that the Medtronic Evolut valve system performs well and lasts for at least five years, with patients experiencing similar survival and stroke rates to those who underwent traditional valve replacement surgery. For the Edwards valve, evidence suggests that over 98% of patients did not require another valve procedure even after ten years. Both treatments show promising results for managing severe aortic stenosis. ^{3 6 7 8 9}

Who Is on the Research Team?

Gregory Fontana, MD

Principal Investigator

Los Robles Regional Medical Center

Guilherme Attizzani, MD

Principal Investigator

UH, Cleveland Medical Center

Basel Ramlawi

Principal Investigator

Lankenau Heart Institute

Are You a Good Fit for This Trial?

Inclusion Criteria

I need a second TAVR due to valve failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo redo Transcatheter Aortic Valve Replacement (TAVR) procedure

Up to 7 days

In-hospital stay until discharge

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Visits at 30 days, 1 year, and annually thereafter

What Are the Treatments Tested in This Trial?

Interventions

• Redo Transcatheter Aortic Valve Replacement

How Is the Trial Designed?

Group I: Medtronic Transcatheter Aortic Valves (TAV) or Edwards Transcatheter Aortic Valves (TAV) Experimental Treatment 2 Interventions

Subjects will receive either a Medtronic TAV or Edwards TAV

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

Citations

1. edwards.com edwards.com/newsroom/news/2025-03-31-new-data-confirm-rapid--unpredictable-progression-

New Data Confirm Rapid, Unpredictable Progression of ... The findings revealed echo alerts increased aortic valve replacement (AVR) treatment rates by 11 percent for all patients with severe AS, and 14 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12596754/

Early Outcomes of Transcatheter Aortic Valve Implantation for ... This systematic review and meta-analysis aimed to compare the clinical and hemodynamic outcomes at 30 days after TAVI using the Myval versus the ...

3. treatheartvalvefailure.com treatheartvalvefailure.com/hcp/about-tavr-by-edwards/patient-outcomes

Patient Outcomes | Heart Valve Failure HCP Reintervention rates are exceedingly low with TAVR—over 98% of patients did not require valve reintervention after 10 years7; TAVR by Edwards demonstrates ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307447

Transcatheter Aortic-Valve Replacement in Low-Risk ... The rate of the composite end point of death, stroke, or rehospitalization at 1 year was significantly lower with transcatheter aortic-valve replacement (TAVR)

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03042104

Study Details | NCT03042104 | EARLY TAVR: Evaluation ... This study will evaluate the safety and effectiveness of the Edwards SAPIEN 3/SAPIEN 3 Ultra Transcatheter Heart Valve (THV) compared with clinical surveillance ...

6. edwards.com edwards.com/newsroom/news/2024-06-05-five-year-data-show-excellent-outcomes-for-female-

Five-Year Data Show Excellent Outcomes for Female and ... Through five-year follow up of more than 1,300 low and intermediate risk SAPIEN 3 valve patients there were excellent clinical outcomes and ...

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

5-Year Outcomes After Transcatheter or Surgical Aortic ... Including the vital status sweep data, the all-cause mortality rate at 5 years for patients undergoing TAVR was 14.7% and for surgery was 15.2% (P = 0.74) ( ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6462665/

Outcomes of transcatheter aortic valve replacement in ... One-year mortality rate in the BAV population was 13.1% compared to 15.4% in the TAV patients (P=0.75). Patients with BAV had significantly more moderate to ...

9. eurointervention.pcronline.com eurointervention.pcronline.com/article/sapien-3-ultra-balloon-expandable-transcatheter-aortic-valve-in-hospital-and-30-day-results-from-the-multicentre-s3u-registry

In-hospital and thirty-day outcomes of the SAPIEN 3 Ultra ... 1) Device success was observed in 98% of the cases. · 2) In-hospital, there were no cases of death, stroke or conversion to open heart surgery. · 3) Valve ...