Complex Congenital Heart DefectNCT04860765
COMPASSION S3 Post-Approval Study
An observational study of Complex Congenital Heart Defect and Dysfunctional RVOT Conduit, run by Edwards Lifesciences at 19 sites in United States.
Trial summary
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency
- What is being tested?
- SAPIEN 3 THV
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 19 sitesUnited States
- Study dates
- 13 Apr 2021to Aug 2030
- 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 a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention
Who may be able to join
- Dysfunctional RVOT conduit or previously implanted surgical valve
- RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
Who cannot join
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis or other active infections
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Children's Hospital of Colorado
Aurora, Colorado, 80045
Dell Children's
Austin, Texas, 78723
University of Alabama
Birmingham, Alabama, 35487
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Virginia
Charlottesville, Virginia, 22908
Cincinatti Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43215
Children's Health Dallas
Dallas, Texas, 75235
Duke University
Durham, North Carolina, 27710
Cedars Sinai
Los Angeles, California, 90048
Minneapolis Heart
Minneapolis, Minnesota, 55407
Mount Sinai
New York, New York, 10029
Columbia University Medical Center/NYPH
New York, New York, 10032
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Advocate Childrens Hospital
Oak Lawn, Illinois, 60453
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 19146
Primary Children's
Salt Lake City, Utah, 84108
St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
Read the detailed description
This is a single arm, prospective, multicenter post-approval study.
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Pulmonary Valve; Obstruction
- Being tested
- SAPIEN 3 THV
- Keywords
- Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation, SAPIEN 3
- Medical subject headings
- Pulmonary Valve Insufficiency, Bites and Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN 3 THVDevice
SAPIEN 3 THV in the pulmonic position
| Study group | Role | What they receive |
|---|---|---|
| TPVR | Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). Receives: Device: SAPIEN 3 THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Success
Defined as a composite of:
- Single THV implanted in the desired location
- Right ventricle to pulmonary artery peak-to-peak gradient < 35 mmHg post-implantation
- Less than moderate PR by discharge TTE
- Free of explant at 24 hours post-implantation
Measured: Discharge, expected to be within 1-5 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start13 Apr 2021
- Primary completionAug 2030 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complex Congenital Heart DefectStudies 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
- NCT04860765
- Sponsor's protocol ID
- 2020-07
- Status last verified
- Jan 2026
- First submitted
- 23 Apr 2021
- Last updated
- 3 Feb 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Congenital Multicenter Trial of Pulmonic Valve Dysfunction Studying the SAPIEN 3 Interventional THV Post-Approval Study
- ClinicalTrials.gov ID
- NCT04860765
- Acronym / sponsor ID
- 2020-07
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration, Pulmonary Valve; Obstruction
- Keywords
- Transcatheter pulmonary valve replacement, Transcatheter pulmonary valve implantation, SAPIEN 3
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 13 Apr 2021 (actual)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 27 Apr 2021 (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 of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.
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: SAPIEN 3 THVSubjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position will undergo transcatheter pulmonary valve replacement (TPVR). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with a dysfunctional RVOT conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention
Key inclusion criteria (2 listed)
- Dysfunctional RVOT conduit or previously implanted surgical valve
- RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg
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 |
|---|---|---|
| SAPIEN 3 THVSAPIEN 3 THV in the pulmonic position | Device | TPVR |
Primary outcome
Device Success
Time frame: Discharge, expected to be within 1-5 days post-procedure
Defined as a composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery peak-to-peak gradient < 35 mmHg post-implantation * Less than moderate PR by discharge TTE * Free of 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 3 Feb 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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complex Congenital Heart Defect and Dysfunctional RVOT Conduit, run by Edwards Lifesciences at 19 sites in United States.
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 2 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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?
Device Success (time frame: Discharge, expected to be within 1-5 days 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 3 Feb 2026.