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Transcatheter Heart Valve

SAPIEN 3 THV for Aortic Stenosis (P3 Trial)

N/A
Waitlist Available
Led By Martin B Leon, MD, FACC
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Severe, calcific aortic stenosis
Must not have
History of cirrhosis or any active liver disease
Leukopenia, anemia, thrombocytopenia, history of bleeding diathesis or coagulopathy, or hypercoagulable states
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new heart valve to see if it is safe and effective in patients with severe aortic stenosis who are at low risk for standard aortic valve replacement.

Who is the study for?
The PARTNER 3 Trial is for patients with severe, calcified aortic stenosis who are at low risk for standard valve replacement surgery. Participants must have symptoms or test results showing heart function issues and agree to the study's terms. Those with recent strokes, extreme obesity, short life expectancy, refusal of blood products, certain infections or diseases, unsuitable heart valve sizes or conditions that prevent safe procedure completion cannot join.
What is being tested?
This trial tests the safety and effectiveness of the SAPIEN 3 Transcatheter Heart Valve (THV) compared to standard surgical aortic valve replacement (SAVR). It targets patients with severe aortic stenosis but considered low-risk for traditional surgery. The goal is to see if THV can be an alternative treatment option.
What are the potential side effects?
Potential side effects may include risks associated with heart procedures such as bleeding, infection at the catheter insertion site, irregular heartbeats, stroke, kidney damage from contrast dye used in imaging during the procedure and possible need for pacemaker implantation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have severe narrowing of my heart's aortic valve with calcium buildup.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of cirrhosis or currently have liver disease.
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I have a blood disorder affecting my white cells, red cells, or platelets.
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I have kidney problems or am on dialysis.
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I don't have major aortic disease that would make surgery risky.
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My aortic valve is either one-flap, two-flap, or not hardened by calcium.
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I haven't needed heart or lung support machines in the last 30 days.
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My heart's pumping ability is significantly reduced.
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I cannot take blood thinning medications during or after my valve surgery.
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I have severe lung disease or need home oxygen.
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I am allergic to iodine-based contrast and cannot be treated with pre-medication.
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I have severe high blood pressure in the lungs.
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I refuse to receive blood products.
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I have a specific heart artery condition without a stent or bypass.
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I have a thickened heart muscle that obstructs blood flow.
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My blood vessels in the hip area cannot safely allow for certain medical procedures.
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I have chest conditions or past surgery complications that make another chest surgery unsafe.
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My heart valve condition is severe.
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I can move enough to complete the study's required procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
Secondary study objectives
All Stroke
Death or Stroke
Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points
+2 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: Transcatheter aortic valve replacement (TAVR)Experimental Treatment1 Intervention
Group II: Surgical aortic valve replacement (SAVR)Active Control1 Intervention

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,017 Total Patients Enrolled
Martin B Leon, MD, FACCPrincipal InvestigatorColumbia University Medical Center/ New York Presbyterian Hospital, NY
Michael J Mack, MD, FACCPrincipal InvestigatorThe Heart Hospital Baylor Plano, TX

Media Library

SAPIEN 3 THV (Transcatheter Heart Valve) Clinical Trial Eligibility Overview. Trial Name: NCT02675114 — N/A
Aortic Stenosis Research Study Groups: Surgical aortic valve replacement (SAVR), Transcatheter aortic valve replacement (TAVR)
Aortic Stenosis Clinical Trial 2023: SAPIEN 3 THV Highlights & Side Effects. Trial Name: NCT02675114 — N/A
SAPIEN 3 THV (Transcatheter Heart Valve) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02675114 — N/A
~103 spots leftby Nov 2025
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