What side effects are associated with this type of intervention?

Transcatheter aortic valve replacement (TAVR), including the Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA systems, is a common treatment for aortic valve stenosis. Known side effects of TAVR include vascular complications, such as bleeding or damage to blood vessels, and paravalvular leaks, where blood leaks around the new valve. Additionally, there is an increased risk of requiring a permanent pacemaker post-procedure due to conduction disturbances. Other potential side effects include stroke, kidney injury, and infection. Despite these risks, TAVR is generally considered less invasive than open-heart surgery and offers a quicker recovery time.

What prior FDA approvals exist?

The FDA has approved several transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve stenosis, aimed at improving blood flow and reducing symptoms. Notable approvals include the Edwards SAPIEN series, starting with the original SAPIEN valve, followed by the SAPIEN XT, and the SAPIEN 3, which offered advancements in reducing vascular complications and paravalvular leaks. The latest in this series, the SAPIEN 3 Ultra and SAPIEN 3 Ultra RESILIA, continue to build on these improvements, providing enhanced safety and effectiveness for patients with moderate to severe aortic stenosis.

What other types of research exist?

Promising alternatives to the Edwards SAPIEN 3 systems for aortic valve stenosis patients include the Medtronic CoreValve Evolut PRO+ and the Boston Scientific ACURATE neo2. Both devices have demonstrated positive outcomes in clinical trials and are expected to be viable options in 2024.

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Transcatheter Heart Valve

TAVR for Aortic Stenosis (PROGRESS Trial)

N/A

Recruiting

Led By Raj Makkar, MD

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderate aortic stenosis

65 years of age or older at time of randomization

Must not have

Coronary or aortic valve anatomy that increases the risk of coronary artery obstruction post-TAVR

Anatomical characteristics that would preclude safe transfemoral placement of the introducer sheath or safe passage of the delivery system

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include risks associated with heart valve replacement such as bleeding complications, blood vessel complications at the site where devices are inserted (groin), irregular heartbeat rhythms that might require a permanent pacemaker implantation, stroke risk during and after the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with moderate aortic stenosis.

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I am 65 years old or older.

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I have heart problems or damage.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My heart's pumping ability is severely reduced.

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I have severe leakage in my aortic valve.

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My aortic valve is either unicuspid or not hardened by calcium.

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I have had a procedure to open my aortic valve.

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My heart valve has two flaps with a large aneurysm or severe calcification.

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My heart has a calcification risk that could complicate valve replacement.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Effectiveness Endpoint

Primary Safety Endpoint

Secondary study objectives

Death, stroke, or unplanned cardiovascular hospitalization

Death, unplanned cardiovascular hospitalization, or decrease of > 10 points in Kansas City Cardiomyopathy Questionnaire (KCCQ)

Diastolic dysfunction ≥ Grade 2

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: TAVRExperimental Treatment1 Intervention

Transcatheter Aortic Valve Replacement (TAVR)

Group II: CSActive Control1 Intervention

Clinical Surveillance (CS)

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcatheter Aortic Valve Replacement (TAVR) is a minimally invasive procedure used to treat Aortic Valve Stenosis, a condition where the aortic valve narrows, restricting blood flow from the heart to the rest of the body. During TAVR, a new valve is inserted via a catheter through a blood vessel, typically in the leg, and guided to the heart. The new valve is then expanded, pushing the old, narrowed valve aside and taking over its function. This procedure improves blood flow, reduces symptoms such as shortness of breath and chest pain, and enhances overall quality of life. TAVR is particularly beneficial for patients who are at high risk for traditional open-heart surgery due to its less invasive nature and quicker recovery times.