Pulmonary Valve InsufficiencyNCT02987387
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
An observational study of Pulmonary Valve Insufficiency and Pulmonary Valve Stenosis, run by Edwards Lifesciences at 12 sites in United States.
Trial summary
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital
- What is being tested?
- SAPIEN XT THV
- Type of treatment
- Medical device
- How many people
- 57 participants
- Where
- 12 sitesUnited States
- Study dates
- 17 Jul 2017to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.
Who may be able to join
- Patient has a dysfunctional, non-compliant RVOT conduit.
- The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Who cannot join
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Alabama
Birmingham, Alabama, 35294
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Hospital of Michigan
Detroit, Michigan, 48201
The University of Iowa
Iowa City, Iowa, 52242
Children's Heart Center Nevada
Las Vegas, Nevada, 89109
Mount Sinai Beth Israel
New York, New York, 10003
Newark Beth Israel Medical Center
Newark, New Jersey, 07112
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: New Enrollment SAPIEN XT Post-Approval Study
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
Read the detailed description
The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases
- Being tested
- SAPIEN XT THV
- Keywords
- Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, Pulmonary Atresia, Pulmonary Stenosis
- Medical subject headings
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases, Tetralogy of Fallot, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAPIEN XT THVDevice
SAPIEN XT THV will be implanted in the pulmonic position.
| Study group | Role | What they receive |
|---|---|---|
| TPVI | Transcatheter Pulmonary Valve Implantation with the SAPIEN XT THV Receives: Device: SAPIEN XT THV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device- or procedure-related death or reintervention
Measured: 1 year
Secondary outcomes (3)
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
Assessed via transthoracic echocardiogram (TTE)
Measured: 1 year
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions
Assessed via TTE
Measured: 1 year
Device Success
Device Success is a composite of:
- Deployment of the valve to the target area, and
- Removal of the delivery catheter out of the body, and
- Improvement in pulmonary regurgitation to mild or less per the earliest evaluable TTE.
Measured: 48 Hours Prior to Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study start17 Jul 2017
- Primary completion9 Aug 2021
- Study completion30 Sep 2025
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
- 57 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
- NCT02987387
- Sponsor's protocol ID
- 2015-10
- Status last verified
- Sep 2025
- First submitted
- 19 Oct 2016
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Enrollment SAPIEN XT Post-Approval Study
- ClinicalTrials.gov ID
- NCT02987387
- Acronym / sponsor ID
- 2015-10
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities, Cardiovascular Diseases, Heart Diseases
- Keywords
- Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, Pulmonary Atresia, Pulmonary Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 9 Aug 2021 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 8 Dec 2016 (estimated)
- 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 confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention in a post-market setting.
Detailed description
The study is a prospective, non-randomized, multi-center clinical study to assess the safety and effectiveness of pulmonic implantation of the SAPIEN THV in patients with dysfunctional RVOT conduits requiring treatment for moderate or severe pulmonary regurgitation (PR) by transthoracic echocardiography (TTE) and/or RVOT conduit obstruction with a mean gradient of ≥ 35 mmHg by TTE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPVI | – | Device: SAPIEN XT THVTranscatheter Pulmonary Valve Implantation with the SAPIEN XT THV |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (RVOT) conduit with a clinical indication for intervention.
Key inclusion criteria (2 listed)
- Patient has a dysfunctional, non-compliant RVOT conduit.
- The patient/patient's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Key exclusion criteria (2 listed)
- Inability to tolerate an anticoagulation/antiplatelet regimen
- Active bacterial endocarditis
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 XT THVSAPIEN XT THV will be implanted in the pulmonic position. | Device | TPVI |
Primary outcome
Freedom from device- or procedure-related death or reintervention
Time frame: 1 year
3 secondary outcomes
Decrease in pulmonary regurgitation to mild or less for regurgitant lesions
Time frame: 1 year
Decrease in RVOT mean gradient to less than 30 mmHg for stenotic lesions
Time frame: 1 year
Device Success
Time frame: 48 Hours Prior to Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Valve Insufficiency and Pulmonary Valve Stenosis, run by Edwards Lifesciences at 12 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: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Freedom from device- or procedure-related death or reintervention (time frame: 1 year). 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 15 Dec 2025.