Pulmonary Valve InsufficiencyNCT05378386
ALTERRA Post-Approval Study
An observational study of Pulmonary Valve Insufficiency and Complex Congenital Heart Defect, run by Edwards Lifesciences at 24 sites in 2 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot
- What is being tested?
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 24 sitesin 2 countries
- Study dates
- 12 May 2022to Jul 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
Trial locations and contacts
24 sites in 2 countries.
24 sites in 2 countries
United States23 sites
Colorado Children's Hospital
Aurora, Colorado, 80045
Children's of Alabama
Birmingham, Alabama, 35233
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Medical City Dallas
Dallas, Texas, 75230
Duke University
Durham, North Carolina, 27710
UF Health Shands Hospital
Gainesville, Florida, 32669
Children's Memorial Hermann Hospital
Houston, Texas, 77030
Texas Children's Hospital
Houston, Texas, 77030
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Cedars Sinai Medical Center
Los Angeles, California, 90048
Le Bonheur Children's Hospital
Memphis, Tennessee, 38103
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Columbia University
New York, New York, 10032
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Primary Children's Hospital
Salt Lake City, Utah, 84113
Rady Children's Hospital
San Diego, California, 92123
Seattle Children's Hospital
Seattle, Washington, 98105
Washington University in St. Louis
St Louis, Missouri, 63130
Stanford University
Stanford, California, 94305
St. Joseph's Children's Hospital
Tampa, Florida, 33607
About this study
Official title: 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
Read the detailed description
This is a single arm, prospective, multicenter post-approval study.
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly
- Being tested
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Keywords
- Alterra prestent, SAPIEN 3, Pulmonic Delivery System, Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation
- Medical subject headings
- Pulmonary Valve Insufficiency, Tetralogy of Fallot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve SystemDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| TPVR | Transcatheter Pulmonary Valve Replacement Receives: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Device Success
Acute Device Success, defined as a non-hierarchical composite of:
- Single Alterra deployed in the desired location
- Single THV implanted in the desired location within Alterra
- Right ventricle-pulmonary artery peak-to-peak gradient < 35 mmHg post-THV implantation
- Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram
- Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation
Measured: 24 hours post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start12 May 2022
- Primary completion25 Sep 2025
- Study completionJul 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Valve InsufficiencyStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05378386
- Sponsor's protocol ID
- 2021-11
- Status last verified
- Oct 2026
- First submitted
- 12 May 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent
- ClinicalTrials.gov ID
- NCT05378386
- Acronym / sponsor ID
- 2021-11
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation, RVOT Anomaly
- Keywords
- Alterra prestent, SAPIEN 3, Pulmonic Delivery System, Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 12 May 2022 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- Jul 2035 (estimated)
- First posted
- 18 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a single arm, prospective, multicenter post-approval study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPVR | – | Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve SystemTranscatheter Pulmonary Valve Replacement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve SystemThe 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). | Device | TPVR |
Primary outcome
Acute Device Success
Time frame: 24 hours post-procedure
Acute Device Success, defined as a non-hierarchical composite of: * Single Alterra deployed in the desired location * Single THV implanted in the desired location within Alterra * Right ventricle-pulmonary artery peak-to-peak gradient < 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation (PR) by discharge transthoracic echocardiogram * Free of Alterra/SAPIEN 3 explant at 24 hours post-implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
24 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Valve Insufficiency and Complex Congenital Heart Defect, run by Edwards Lifesciences at 24 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in United States, Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Device Success (time frame: 24 hours post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.