- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05378386
ALTERRA Post-Approval Study
March 12, 2024 updated by: Edwards Lifesciences
Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a single arm, prospective, multicenter post-approval study.
Study Type
Observational
Enrollment (Estimated)
150
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Edwards THV Clinical Affairs
- Phone Number: 949-250-2500
- Email: THV_CT.gov@Edwards.com
Study Locations
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Petah Tikva, Israel
- Recruiting
- Schneider Children's Medical Center of Israel
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Alabama
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Birmingham, Alabama, United States, 35233
- Recruiting
- Children's of Alabama
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Arkansas
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Little Rock, Arkansas, United States, 72202
- Recruiting
- Arkansas Children's Hospital
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California
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Los Angeles, California, United States, 90048
- Recruiting
- Cedars Sinai Medical Center
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San Diego, California, United States, 92123
- Recruiting
- Rady's Children's Hospital
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Stanford, California, United States, 94305
- Recruiting
- Stanford University
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Colorado
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Aurora, Colorado, United States, 80045
- Recruiting
- Colorado Children's Hospital
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Illinois
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Oak Lawn, Illinois, United States, 60453
- Recruiting
- Advocate Children's Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Recruiting
- Boston Children's Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Withdrawn
- Mayo Clinic
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Missouri
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Saint Louis, Missouri, United States, 63130
- Recruiting
- Washington University in St. Louis
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New York
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New York, New York, United States, 10029
- Recruiting
- Icahn School Of Medicine At Mount Sinai
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New York, New York, United States, 10032
- Recruiting
- Columbia University
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North Carolina
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Durham, North Carolina, United States, 27710
- Recruiting
- Duke University
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Ohio
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Cincinnati, Ohio, United States, 45229
- Recruiting
- Cincinnati Children's Hospital
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Columbus, Ohio, United States, 43205
- Recruiting
- Nationwide Children's Hospital
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15224
- Recruiting
- UPMC Children's Hospital of Pittsburgh
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Texas
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Dallas, Texas, United States, 75230
- Recruiting
- Medical City Dallas
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Houston, Texas, United States, 77030
- Recruiting
- Texas Children's Hospital
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Utah
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Salt Lake City, Utah, United States, 84113
- Recruiting
- Primary Children's Hospital
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Virginia
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Charlottesville, Virginia, United States, 22908
- Recruiting
- University of Virginia
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Washington
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Seattle, Washington, United States, 98105
- Recruiting
- Seattle Children's Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Subjects with severe PR who have a native or surgically-repaired RVOT, are clinically indicated for pulmonary valve replacement, and are planned for treatment with the Alterra prestent and SAPIEN 3 THV
Description
Inclusion Criteria:
- Native or surgically-repaired RVOT with severe PR
- Clinically indicated for pulmonary valve replacement
- Planned for treatment with the Alterra prestent and SAPIEN 3 THV
Exclusion Criteria:
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TPVR
Transcatheter Pulmonary Valve Replacement
|
The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular right ventricular outflow tracts (RVOTs) and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 transcatheter heart valve (THV).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Device Success
Time Frame: 24 hours post-procedure
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Acute Device Success, defined as a non-hierarchical composite of:
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24 hours post-procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 12, 2022
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2034
Study Registration Dates
First Submitted
May 12, 2022
First Submitted That Met QC Criteria
May 12, 2022
First Posted (Actual)
May 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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