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Prestent
Alterra Prestent + SAPIEN 3 Valve for Heart Disease
N/A
Waitlist Available
Led By Evan Zahn, MD, FACC, FSCAI
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight is ≥ 20 kg (44 lbs).
Must not have
Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Summary
This trial is testing a new heart valve to see if it is safe and effective in people with a dysfunctional right ventricular outflow tract/pulmonary valve. If the trial is successful, subjects will be eligible for enrollment in the continued access phase.
Who is the study for?
This trial is for individuals weighing at least 44 lbs with certain heart conditions like Tetralogy of Fallot, who have moderate or severe pulmonary regurgitation. They must have specific measurements in their heart's outflow tract and agree to the study terms. People can't join if they've had recent medical procedures, drug abuse history, are pregnant, have serious non-cardiac diseases, infections requiring antibiotics, blood disorders or known allergies to specific metals and medications.
What is being tested?
The ALTERRA trial tests the safety and effectiveness of combining two devices: the Edwards Alterra Adaptive Prestent and SAPIEN 3 THV System. This combo aims to treat patients with dysfunctional right ventricular outflow tracts/pulmonary valves due to congenital heart defects.
What are the potential side effects?
Potential side effects may include complications related to device placement such as bleeding or infection at the insertion site, allergic reactions to materials in the devices or contrast media used during implantation, irregular heartbeat patterns (arrhythmias), valve leakage or migration.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 44 pounds.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a surgery or heart-related procedure planned within 30 days after my valve implant.
Select...
My non-heart related illness may shorten my life to under a year.
Select...
I am allergic to aspirin or heparin and cannot take similar medications.
Select...
My kidney function is low or I am on dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Main Cohort: THV Dysfunction
PDS Registry: Acute PDS Success
Secondary study objectives
Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
Trial Design
2Treatment groups
Experimental Treatment
Group I: TPVR - PDS RegistryExperimental Treatment1 Intervention
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).
Group II: TPVR - Main CohortExperimental Treatment1 Intervention
Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
182 Previous Clinical Trials
62,955 Total Patients Enrolled
Evan Zahn, MD, FACC, FSCAIPrincipal InvestigatorCedars-Sinai Heart Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had any surgery or interventional procedures in the last 30 days.I have a surgery or heart-related procedure planned within 30 days after my valve implant.Your body doesn't have the right shape for the Alterra Adaptive Prestent or the SAPIEN 3 THV to be put in.I have not had endocarditis or been treated for it in the last 6 months.You have used drugs through a needle in the past or currently.The size of the landing zone in the heart's pulmonary valve area is between 27mm and 38mm, and the distance from the heart's contracting tissue to the lowest pulmonary artery takeoff is at least 35mm.I weigh at least 44 pounds.You are allergic to nitinol, cobalt-chromium, nickel, or contrast dye, and cannot take medication to prevent an allergic reaction.You have moderate or severe pulmonary regurgitation as seen in a heart ultrasound.I need a procedure to close a hole in my heart or other heart-related procedures, not including artery stenting.If you're a woman who could get pregnant, you have a positive pregnancy test.My non-heart related illness may shorten my life to under a year.You have low white blood cell count, low red blood cell count, low platelet count, or any known blood clotting disorder.I am not currently on antibiotics for an infection, or it has been 2 weeks since I finished them.I am allergic to aspirin or heparin and cannot take similar medications.My kidney function is low or I am on dialysis.
Research Study Groups:
This trial has the following groups:- Group 1: TPVR - Main Cohort
- Group 2: TPVR - PDS 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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