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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 belowSelect...
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:Select...
I have a history of cirrhosis or currently have liver disease.
Select...
I have a blood disorder affecting my white cells, red cells, or platelets.
Select...
I have kidney problems or am on dialysis.
Select...
I don't have major aortic disease that would make surgery risky.
Select...
My aortic valve is either one-flap, two-flap, or not hardened by calcium.
Select...
I haven't needed heart or lung support machines in the last 30 days.
Select...
My heart's pumping ability is significantly reduced.
Select...
I cannot take blood thinning medications during or after my valve surgery.
Select...
I have severe lung disease or need home oxygen.
Select...
I am allergic to iodine-based contrast and cannot be treated with pre-medication.
Select...
I have severe high blood pressure in the lungs.
Select...
I refuse to receive blood products.
Select...
I have a specific heart artery condition without a stent or bypass.
Select...
I have a thickened heart muscle that obstructs blood flow.
Select...
My blood vessels in the hip area cannot safely allow for certain medical procedures.
Select...
I have chest conditions or past surgery complications that make another chest surgery unsafe.
Select...
My heart valve condition is severe.
Select...
I can move enough to complete the study's required procedures.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreAwards & 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
62,108 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
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of cirrhosis or currently have liver disease.I have a blood disorder affecting my white cells, red cells, or platelets.I have not had a stroke or mini-stroke in the last 3 months.I have kidney problems or am on dialysis.I have not had active bacterial endocarditis in the last 6 months.A group of heart doctors decides that the patient has a high risk of dying from surgery and has a Society of Thoracic Surgeons (STS) score of less than 4.I have symptoms from narrowed neck arteries or had treatment for it within the last month.You have a mass or blood clot in your heart shown in a heart imaging test.I don't have major aortic disease that would make surgery risky.I have heart issues affecting my daily activities or exercise ability.I haven't needed heart or lung support machines in the last 30 days.My heart's pumping ability is significantly reduced.I cannot take blood thinning medications during or after my valve surgery.I have severe lung disease or need home oxygen.My aortic valve is either one-flap, two-flap, or not hardened by calcium.I am allergic to iodine-based contrast and cannot be treated with pre-medication.I have severe high blood pressure in the lungs.You have a mechanical or bioprosthetic heart valve.I have severe narrowing of my heart's aortic valve with calcium buildup.I am not eligible for either part of the study.Doctors think you may have less than 2 years to live.You weigh more than 110 pounds for every 4.9 feet of your height.I refuse to receive blood products.I have a specific heart artery condition without a stent or bypass.A team of heart doctors has decided that the best treatment for your heart condition is not possible.You had a heart attack within 30 days before the study starts.I have a thickened heart muscle that obstructs blood flow.My blood vessels in the hip area cannot safely allow for certain medical procedures.I have chest conditions or past surgery complications that make another chest surgery unsafe.My heart valve condition is severe.You have a serious problem with the aortic valve in your heart.Your aortic valve is not the right size for the available transcatheter heart valve options.The Heart Team has determined that you are significantly frail.I can move enough to complete the study's required procedures.Your Syntax score is higher than 32.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical aortic valve replacement (SAVR)
- Group 2: Transcatheter aortic valve replacement (TAVR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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