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Transcatheter Heart Valve
SAPIEN X4 THV for Aortic Stenosis
N/A
Recruiting
Led By Rahul P. Sharma, MBBS
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 AS
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing a new heart valve to see if it is safe and effective for people with a certain type of heart problem.
Who is the study for?
This trial is for individuals with severe, calcified aortic stenosis who are experiencing symptoms and have at least a moderate functional impairment due to the condition. They must understand the study and consent to participate. Exclusions include pregnancy, recent heart attacks or procedures, certain heart diseases, planned surgeries, extreme obesity (BMI > 50), very low life expectancy or ejection fraction, blood disorders, active infections including COVID-19.Check my eligibility
What is being tested?
The SAPIEN X4 Transcatheter Heart Valve (THV) is being tested for safety and effectiveness in treating symptomatic severe calcific aortic stenosis. The study aims to see if this valve can improve heart function without major surgery by implanting it through a catheter.See study design
What are the potential side effects?
Potential side effects may include risks associated with heart valve replacement such as bleeding complications, irregular heart rhythms, infection risk around the new valve area (endocarditis), stroke risk during implantation procedure and possible need for permanent pacemaker.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have severe, calcified aortic stenosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Non-hierarchical composite of death and stroke
Secondary outcome measures
Favorable outcome per VARC-3: Composite of 1) alive, 2) Kansas City Cardiomyopathy Questionnaire (KCCQ) score ≥ 60, and 3) KCCQ score decrease ≤10 points from baseline
New permanent pacemaker implantation
Paravalvular leak
Trial Design
2Treatment groups
Experimental Treatment
Group I: TAVR - Main CohortExperimental Treatment1 Intervention
Subjects will undergo transcatheter aortic valve replacement (TAVR)
Group II: TAVR - Bicuspid RegistryExperimental Treatment1 Intervention
Subjects with bicuspid aortic valve morphology will undergo TAVR
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
Aortic stenosis is commonly treated with transcatheter aortic valve replacement (TAVR), especially in patients who are at high risk for surgical aortic valve replacement (SAVR). TAVR involves the insertion of a new valve via a catheter, which is threaded through the blood vessels to the heart, where it replaces the narrowed aortic valve without the need for open-heart surgery.
This procedure improves blood flow by ensuring the new valve opens and closes properly, reducing the heart's workload and alleviating symptoms such as shortness of breath and chest pain. The Edwards SAPIEN X4 THV, being studied for its safety and effectiveness, represents an advancement in TAVR technology, potentially offering better outcomes and fewer complications for patients with severe, symptomatic aortic stenosis.
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,475 Total Patients Enrolled
Rahul P. Sharma, MBBSPrincipal InvestigatorStanford University
1 Previous Clinical Trials
200 Total Patients Enrolled
Tamim M. Nazif, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
200 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a heart attack in the last 30 days.I have severe, calcified aortic stenosis.I have severe leaking or significant narrowing of my mitral heart valve.I cannot take blood thinning medications due to my condition.Your aortic valve size is suitable for the SAPIEN X4 THV.I have not had a stroke or mini-stroke in the last 3 months.I am scheduled for a procedure to treat irregular heartbeat.You have signs of a mass or blood clot in your heart on a heart imaging test.My heart has a calcification risk that could complicate valve implantation.My heart disease cannot be treated with a stent.You have a serious problem with your aortic valve.I have a thickened heart muscle causing blockage below the valve.I am at high risk for blocked arteries after a heart valve implant.I currently have or had COVID-19 with lasting effects.I haven't had any surgery or catheter procedures in the last 30 days, except for planned heart disease treatment.I have no surgeries or heart procedures planned within 30 days after the study, unless it's for treating coronary artery disease.I need a heart valve surgery within the next year.Your heart is not pumping enough blood.I have a condition that increases my risk of blood clots.You have heart-related symptoms that affect your daily activities.I haven't needed heart or lung support machines in the last 30 days.My aortic valve is either one-flap, two-flap, or not hardened by calcium.You weigh more than 110 pounds for every 4.9 feet of your height.I am currently pregnant or breastfeeding.I refuse to receive blood transfusions.I have not had endocarditis in the last 6 months.Doctors think you may live less than 2 years.My body allows for safe placement of medical devices in my thigh area.You have a mechanical or bioprosthetic heart valve.I have kidney problems or am on dialysis.You have a strong allergy to iodinated contrast that cannot be treated with premedication.You have low levels of white blood cells, red blood cells, or platelets in your blood.
Research Study Groups:
This trial has the following groups:- Group 1: TAVR - Main Cohort
- Group 2: TAVR - Bicuspid Registry
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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