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Transcatheter Heart Valve
SAPIEN 3 Valve for Pulmonary Valve Dysfunction
N/A
Recruiting
Led By D. Scott Lim, MD
Research Sponsored by Edwards Lifesciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Weight ≥ 20 kg (44 lbs.)
Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will show whether the Edwards Lifesciences SAPIEN 3 Transcatheter Heart Valve is safe and effective for people with a dysfunctional right ventricular outflow tract or a previous pulmonary valve implant.
Who is the study for?
This trial is for individuals weighing at least 44 lbs with a dysfunctional heart valve or conduit in the pulmonic position, requiring intervention and having specific measurements. Participants must not have active infections, blood disorders, recent procedures, or severe non-cardiac diseases affecting life expectancy. Pregnant women and those with certain allergies are excluded.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve Systems in patients needing pulmonary valve replacement due to dysfunction. It aims to improve heart function by replacing the faulty valve without open-heart surgery.See study design
What are the potential side effects?
Potential side effects may include bleeding complications, irregular heart rhythms, infection risks associated with implantation procedures, allergic reactions to materials used in valves or medications during procedure, and possible damage to nearby heart structures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I weigh at least 44 pounds.
Select...
I need a procedure for my heart valve and the area where it will be placed fits the required size.
Select...
My heart valve condition is moderate or severe, or my heart has a specific high pressure.
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
THV dysfunction
Secondary outcome measures
Coronary artery compression requiring intervention
Death (all-cause, procedural and device-related)
Device Success
+7 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: TPVR- S3UR RegistryExperimental Treatment2 Interventions
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
Group II: TPVR - THV RegistryExperimental Treatment2 Interventions
Subjects with a previously implanted transcatheter valve in the pulmonic position will undergo TPVR.
Group III: TPVR - Main CohortExperimental Treatment1 Intervention
Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR).
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Who is running the clinical trial?
Edwards LifesciencesLead Sponsor
180 Previous Clinical Trials
61,466 Total Patients Enrolled
D. Scott Lim, MDPrincipal InvestigatorUniversity of Virginia Medical Center
1 Previous Clinical Trials
400 Total Patients Enrolled
Vasilis Babaliaros, MDPrincipal InvestigatorEmory University Hospitals
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have low white blood cell, red blood cell, or platelet counts, or a known blood clotting disorder.I am not currently on antibiotics for an infection, or it has been 2 weeks since I finished them.I have a planned surgery or heart procedure within 30 days after the TPVI procedure.You have used drugs by injecting them into your veins in the past or currently.Your heart arteries are compressed in a way that would be affected by the pulmonic valve replacement procedure.My body's structure doesn't allow for the study valve to be inserted through my thigh.I need a procedure to close a hole in my heart but not for artery issues.I am currently pregnant or breastfeeding.I weigh at least 44 pounds.I need a procedure for my heart valve and the area where it will be placed fits the required size.I have not had any surgery or interventional procedures within the last 30 days.My heart valve condition is moderate or severe, or my heart has a specific high pressure.You are allergic to cobalt-chromium, nickel, or contrast dye that cannot be managed with premedication.My non-heart related illness may shorten my life to under a year.I have not had endocarditis or been treated for it in the last 6 months.I am allergic to aspirin or heparin and cannot take similar medications.
Research Study Groups:
This trial has the following groups:- Group 1: TPVR- S3UR Registry
- Group 2: TPVR - Main Cohort
- Group 3: TPVR - THV 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many healthcare facilities are administering this clinical trial?
"The University of Virginia (UVA) in Charlottesville, the Lindner Research Center at Christ Hospital in Cincinnati, and the University of Washington/Seattle Children's Hospital are all participating clinical sites for this research trial. Additionally, there is availability at 11 other locations."
Answered by AI
Is this study actively recruiting participants at the moment?
"According to the information on clinicaltrials.gov, individuals are presently sought for this trial which was initially made available on July 5th 2016 and revised most recently on March 9th 2022."
Answered by AI
How many participants are engaging with this clinical trial?
"Affirmative. The particulars of this trial are currently hosted on clinicaltrials.gov and show that the study is actively searching for 108 participants from 11 different locations. This medical study was initially listed online on July 5th, 2016 and has been revised as recently as March 9th, 2022."
Answered by AI
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