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Transcatheter Heart Valve

TAVR for Aortic Stenosis (PROGRESS Trial)

Mineola, NY
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.

See full description
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.Check my eligibility
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.See study design
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.
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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.
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Timeline

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)

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.

Find a Location

Closest Location:Winthrop-University Hospital· Mineola, NY

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
185 Previous Clinical Trials
63,208 Total Patients Enrolled
61 Trials studying Aortic Valve Stenosis
30,591 Patients Enrolled for Aortic Valve Stenosis
Raj Makkar, MDPrincipal InvestigatorCedars-Sinai Medical Center, Los Angeles, CA, USA
5 Previous Clinical Trials
4,293 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
250 Patients Enrolled for Aortic Valve Stenosis
Jeroen J Bax, MD, PhDPrincipal InvestigatorLeiden University Medical Center, Leiden, The Netherlands
Philippe Généreux, MDPrincipal InvestigatorMorristown Medical Center, Morristown, NJ, USA
4 Previous Clinical Trials
3,379 Total Patients Enrolled
1 Trials studying Aortic Valve Stenosis
901 Patients Enrolled for Aortic Valve Stenosis

Media Library

Edwards SAPIEN 3/ SAPIEN 3 Ultra (Transcatheter Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT04889872 — N/A
Aortic Valve Stenosis Research Study Groups: TAVR, CS
Aortic Valve Stenosis Clinical Trial 2023: Edwards SAPIEN 3/ SAPIEN 3 Ultra Highlights & Side Effects. Trial Name: NCT04889872 — N/A
Edwards SAPIEN 3/ SAPIEN 3 Ultra (Transcatheter Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04889872 — N/A
~1261 spots leftby Jun 2029