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SAPIEN 3 THV for Aortic Stenosis (P3 Trial)
P3 Trial 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.
P3 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowP3 Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.P3 Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Surgical aortic valve replacement (SAVR)
- Group 2: Transcatheter aortic valve replacement (TAVR)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Is enrollment now open for this medical experiment?
"According to clinicaltrials.gov, the recruitment phase of this trial has closed and it is no longer seeking new candidates; the initial posting was made on March 1st 2016 with a final update taking place in November 18th 2022. However, there are currently 306 other medical studies actively searching for participants."
What is the primary objective of this clinical investigation?
"The primary outcome of this 1-year medical trial will be an assessment of All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart failure). Secondary objectives involve measuring the Number of patients with stroke events, new onset atrial fibrillation, and any cases that resulted in death or a stroke."
In how many venues is this experiment being conducted?
"Patients for this trial can be enrolled at Mount Sinai Medical Center in Miami Beach, California; Stanford Hospital and Clinics in Palo Alto, Connecticut; Sutter Health Sacramento in Sacramento, Colorado; as well as 69 other sites."
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