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Transcatheter Valve Replacement
SAPIEN 3 Ultra System for Aortic Stenosis
N/A
Waitlist Available
Led By John Webb, MD
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 meeting specific transthoracic echocardiogram criteria
New York Heart Association functional class ≥ II
Timeline
Screening 3 weeks
Treatment Varies
Follow Up discharge, expected to be within 1-5 days post-procedure]
Awards & highlights
Study Summary
This trial will show how safe and effective the SAPIEN 3 Ultra System is for people with severe aortic valve disease who are at an intermediate risk for standard aortic valve replacement.
Who is the study for?
This trial is for patients with severe, calcific aortic stenosis who are at intermediate risk for open heart surgery. They must understand the study and consent to participate, have specific heart function classifications (NYHA class ≥ II), and meet certain echocardiogram criteria. Exclusions include complex coronary disease, intolerance to antithrombotic therapy, pregnancy in women of childbearing potential, participation in other studies, certain heart conditions like hypertrophic cardiomyopathy or valve issues, severe ventricular dysfunction or regurgitation problems.Check my eligibility
What is being tested?
The SAPIEN 3 Ultra System is being tested for safety and performance in replacing the aortic valve using a less invasive method than open-heart surgery. This system includes both the delivery mechanism and the actual replacement valve designed specifically for people with narrowed valves due to calcium buildup.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include risks associated with catheter-based procedures such as bleeding at the access site, infection risk from implanted devices or materials used during implantation procedure; possible damage to blood vessels; irregular heartbeats; stroke; kidney damage from contrast dye used during imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve is severely narrowed and has calcium deposits.
Select...
I have moderate to severe heart condition symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ discharge, expected to be within 1-5 days post-procedure]
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~discharge, expected to be within 1-5 days post-procedure]
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Procedural Success
Secondary outcome measures
Major Vascular Complications
Valve Migration or Embolization
Trial Design
1Treatment groups
Experimental Treatment
Group I: Transcatheter Aortic Valve Replacement (TAVR)Experimental Treatment1 Intervention
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,474 Total Patients Enrolled
61 Trials studying Aortic Valve Stenosis
31,685 Patients Enrolled for Aortic Valve Stenosis
John Webb, MDPrincipal InvestigatorSt. Paul's Hospital
5 Previous Clinical Trials
1,527 Total Patients Enrolled
2 Trials studying Aortic Valve Stenosis
199 Patients Enrolled for Aortic Valve Stenosis
Bernard Prendergast, ProfPrincipal InvestigatorSt. Thomas Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a mechanical or bioprosthetic valve in your heart.I have severe high blood pressure in the lungs.I have kidney problems or am on dialysis.I have a history of blood disorders or abnormal bleeding.You weigh more than 110 pounds for every 4.9 feet of your height.Female participants who can become pregnant have a positive pregnancy test.You have a serious problem with your aortic valve.My heart's structure increases the risk of artery blockage after a valve replacement.My heart valve is severely narrowed and has calcium deposits.My heart team considers me at intermediate risk for open heart surgery.I have a thickened heart muscle that obstructs blood flow.I do not have major aortic disease that would make surgery unsafe.I have had recent treatment for narrowed neck arteries or have symptoms of it.I have severe leaking or moderate blockage in my heart's mitral valve.I have severe lung disease or need home oxygen.The doctor thinks you may not live more than 2 years.My blood vessels in the hip area are not suitable for safe medical device insertion.My heart's pumping ability is significantly reduced.I haven't needed help with my breathing or heart function in the last 30 days.The Heart Team has determined that you are very weak and may not be able to tolerate the study procedures.I am scheduled for a procedure to treat irregular heartbeat.There is a picture of a mass, blood clot, or infection in your heart.I refuse to receive blood products.You have a severe allergy to iodinated contrast that can't be managed with pre-medication.I cannot take blood thinning medication during or after my valve surgery.My heart condition involves complex artery issues that can't be fully treated with surgery.The size of your aortic valve is not a match for the available replacement valve sizes according to 3D imaging analysis.My aortic valve is either one-flap, two-flap, or not hardened by calcium.I had a heart attack less than 30 days before my planned valve surgery.I have not had active bacterial endocarditis in the last 6 months.I have not had a stroke or mini-stroke in the last 3 months.I have a history of cirrhosis or another liver disease.I have moderate to severe heart condition symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there a recruitment scheme ongoing for this experiment?
"Clinicaltrials.gov indicates that this particular trial is not presently looking for participants, having been initially posted on June 1st 2018 and last updated November 22nd 2022. Nonetheless, 307 other trials are actively seeking patients at present."
Answered by AI
How many healthcare facilities in the state are administering this trial?
"Currently, this medical trial is available at 4 different sites: Vancouver, Hamilton and Toronto with one additional site. To make the process as easy as possible for participants, it's important to choose a location that requires minimal travel."
Answered by AI
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