TAVR for Aortic Stenosis

(PROGRESS Trial)

Recruiting in Palo Alto (17 mi)

+75 other locations

Overseen by Jeroen J Bax, MD, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Edwards Lifesciences

Disqualifiers: Aortic regurgitation, LVEF < 20%, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial tests advanced heart valves that can be inserted without open-heart surgery in patients with a narrowed and stiff aortic valve due to calcium buildup. The new valve is placed through a small cut and guided to the heart, where it replaces the damaged valve. This minimally invasive procedure has recently become the only lifesaving solution for patients who cannot tolerate standard surgical valve replacement.

Will I have to stop taking my current medications?

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.

What data supports the effectiveness of the treatment Edwards SAPIEN 3/ SAPIEN 3 Ultra, Edwards SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA for aortic stenosis?

Research shows that the SAPIEN 3 valve used in transcatheter aortic valve replacement (TAVR) provides good short-term and long-term outcomes for patients with severe aortic stenosis, especially those at intermediate surgical risk. It has been designed to reduce complications and improve quality of life compared to older devices and surgical options.

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Is TAVR with the SAPIEN 3 valve safe for humans?

TAVR with the SAPIEN 3 valve has shown good short-term safety outcomes in patients with severe aortic stenosis, especially those at high surgical risk. The FDA has approved it for high-risk patients, indicating that its benefits outweigh the risks compared to traditional surgery.

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What makes the SAPIEN 3/SAPIEN 3 Ultra treatment unique for aortic stenosis?

The SAPIEN 3 and SAPIEN 3 Ultra are unique because they are balloon-expandable valves used in transcatheter aortic valve replacement (TAVR), which is less invasive than traditional surgery and suitable for patients at various risk levels, including those who are elderly or have other health conditions that make surgery risky. These valves are designed to reduce complications like paravalvular regurgitation (leakage around the valve) and issues at the site where the valve is inserted.

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Eligibility Criteria

This trial is for people aged 65 or older with moderate, calcific aortic stenosis who may have symptoms or signs of heart damage. They must understand the study and agree to participate. It's not for those with mechanical heart valves, severe valve leakage, very weak hearts (LVEF < 20%), certain types of aortic valves, high risk of artery blockage after TAVR, previous treatments for severe AS, unsuitable heart anatomy for the procedure, or evidence of intracardiac mass.

Inclusion Criteria

The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

I have been diagnosed with moderate aortic stenosis.

I am 65 years old or older.

Exclusion Criteria

My heart's structure increases my risk of artery blockage after a valve replacement.

My body's structure allows for safe placement of medical devices through the thigh.

You have a mechanical or bioprosthetic aortic valve already in place.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either transcatheter aortic valve replacement (TAVR) or clinical surveillance

30 days

1 visit (in-person) for TAVR procedure, regular monitoring for clinical surveillance

Follow-up

Participants are monitored for safety and effectiveness, including primary and secondary endpoints

2 years

Regular follow-up visits (in-person and virtual)

Continued Access

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial

Participant Groups

The PROGRESS trial tests the safety and effectiveness of Edwards SAPIEN Transcatheter Heart Valve systems in treating moderate aortic stenosis. Participants will receive one of these valve systems through a less invasive method compared to traditional surgery.

Group I: TAVR Experimental Treatment 1 Intervention

Transcatheter Aortic Valve Replacement (TAVR)

Group II: CS Active Control 1 Intervention

Clinical Surveillance (CS)

Edwards SAPIEN 3/ SAPIEN 3 Ultra is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Edwards SAPIEN 3 / SAPIEN 3 Ultra for:

• Severe aortic stenosis
• Replacement of failing mitral valve in patients who are too high risk for open-heart surgery when the valve has already been repaired with an artificial (prosthetic) ring
• Replacement of failing previously implanted surgical biological aortic or mitral valve, or transcatheter aortic valve in patients who are too high risk for open-heart surgery

🇪🇺 Approved in European Union as Edwards SAPIEN 3 / SAPIEN 3 Ultra for:

• Severe aortic stenosis
• Symptomatic heart disease due to severe native aortic valve stenosis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Winthrop-University Hospital Mineola, NY

New York University Langone Medical Center New York, NY

Parkwest Medical Center Knoxville, TN

Rochester General Hospital Rochester, NY

More Trial Locations

Who Is Running the Clinical Trial?

Edwards Lifesciences Lead Sponsor

References

1. England pubmed.ncbi.nlm.nih.gov

Transcatheter aortic valve replacement versus surgical valve replacement in intermediate-risk patients: a propensity score analysis. [2022] Transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve demonstrates good 30 day clinical outcomes in patients with severe aortic stenosis who are at intermediate risk of surgical mortality. Here we report longer-term data in intermediate-risk patients given SAPIEN 3 TAVR and compare outcomes to those of intermediate-risk patients given surgical aortic valve replacement.

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

First experience with the new generation Edwards Sapien 3 aortic bioprosthesis: procedural results and short term outcome. [2018] TAVR has become an established treatment for severe symptomatic aortic stenosis in patients with high surgical risk. The latest generation of the balloon-expandable Edwards Sapien device, the Sapien 3, together with its new transfemoral Commander delivery system has been designed to reduce paravalvular regurgitation and vascular access site complications.

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

Transfemoral Aortic Valve Implantation with the New Edwards Sapien 3 Valve for Treatment of Severe Aortic Stenosis-Impact of Valve Size in a Single Center Experience. [2019] The third generation Edwards Sapien 3 (Edwards Lifesciences Inc., Irvine, California) system was optimized to reduce residual aortic regurgitation and vascular complications.

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

Effect of SAPIEN 3 Transcatheter Valve Implantation on Health Status in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER S3i Trial. [2020] The aim of this study was to evaluate whether transcatheter aortic valve replacement (TAVR) with the SAPIEN 3 valve (S3-TAVR) results in improved quality of life (QoL) compared with previous-generation TAVR devices or surgical aortic valve replacement (SAVR).

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

Transcarotid Approach for Transcatheter Aortic Valve Replacement With the Sapien 3 Prosthesis: A Multicenter French Registry. [2020] This study sought to describe the procedural and clinical outcomes of patients undergoing transcarotid (TC) transcatheter aortic valve replacement (TAVR) with the Edwards Sapien 3 device.

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

Hemodynamic comparison of transcatheter aortic valve replacement with the SAPIEN 3 Ultra versus SAPIEN 3: The HomoSAPIEN registry. [2021] The study aims to compare the hemodynamic and clinical outcomes of the SAPIEN 3 Ultra (S3-Ultra) with the SAPIEN 3 (S3) system in patients who underwent transfemoral transcatheter aortic valve replacement (TF-TAVR).

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

Overview of the 2012 Food and Drug Administration Circulatory System Devices Panel of the Medical Devices Advisory Committee meeting on the Edwards SAPIEN transcatheter heart valve for high-risk aortic stenosis patients. [2013] The Edwards SAPIEN transcatheter heart valve (THV) is approved for aortic stenosis patients considered inoperable because of high surgical risk. Based on the high-risk arm of the PARTNER trial, the Food and Drug Administration's Circulatory System Devices Panel reviewed an additional indication for use in high-risk, operable patients. Although several concerns were raised regarding safety, trial misconduct, and several subgroup analyses, most panel members agreed that the Edwards SAPIEN THV (Edwards Lifesciences LLC, Irvine, CA), when used in high-risk patients, is noninferior to surgical aortic valve replacement. The panel voted 11 to 0 (with 1 abstention) that the benefits of the Edwards SAPIEN THV do outweigh the risks for use in the indicated patient population. This summary aims to describe the discussions and recommendations made during the meeting. Based on the panel recommendation, the device was approved by the Food and Drug Administration.

8. England pubmed.ncbi.nlm.nih.gov

Next-generation balloon-expandable transcatheter heart valve: the SAPIEN 3 Ultra valve. [2022] The next generation SAPIEN 3 Ultra (Edwards Lifesciences, CA, USA) builds on the success of the SAPIEN 3 (S3) transcatheter heart valve. The textured polyethylene terephthalate external skirt is 40% taller than the S3 valve skirt. The Edwards Commander delivery system and Edwards eSheath remain unchanged from S3 with proven results regarding valve deliverability and low rates of vascular complications.

9. China pubmed.ncbi.nlm.nih.gov

Early mortality and safety after transcatheter aortic valve replacement using the SAPIEN 3 in nonagenarians. [2022] Transcatheter aortic valve replacement (TAVR) has been performed for many elderly patients with severe aortic stenosis (AS). The SAPIEN 3 is one of the latest balloon-expandable prosthesis. This study aimed to investigate the early clinical outcomes after TAVR using the SAPIEN 3 in nonagenarians.

10. England pubmed.ncbi.nlm.nih.gov

Device profile of the SAPIEN 3 transcatheter heart valve in low-risk patients with aortic stenosis: overview of its safety and efficacy. [2022] Transcatheter aortic valve replacement (TAVR) has become a treatment of reference for patients with symptomatic severe aortic stenosis, and the balloon-expandable SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems are two of the most broadly used worldwide. Lately, TAVR has progressively expanded toward the treatment of low-risk patients.

11. Netherlands pubmed.ncbi.nlm.nih.gov

One-year outcomes of the pivotal clinical trial of a balloon-expandable transcatheter aortic valve implantation in Japanese dialysis patients. [2022] Dialysis patients with aortic stenosis are generally considered as being at extreme or high surgical risk. Herein, the first clinical trial was conducted to investigate clinical safety and effectiveness of transcatheter aortic valve replacement (TAVR) using the balloon-expandable transcatheter aortic valve (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) in Japanese dialysis patients.