Pulmonary DiseaseNCT03130777

ALTERRA: SAPIEN 3 THV With the Alterra Adaptive Prestent

A study testing Edwards Alterra Adaptive Prestent with SAPIEN 3 THV in people with Pulmonary Disease and Transcatheter Pulmonary Valve Replacement (TPVR), run by Edwards Lifesciences at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

To demonstrate the safety and effectiveness of the Edwards Alterra Adaptive Prestent in conjunction with the Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract/pulmonary valve (RVOT/PV) who are indicated for treatment of pulmonary regurgitation… Read more about this study

Who is it for?: Any age
Conditions the study is for: Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot
What is being tested?: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 86 participants
Where: 14 sitesUnited States
Study dates: 22 Aug 2017to Jun 2032
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Weight is ≥ 20 kg (44 lbs).
RVOT/PV with moderate or greater PR by TTE.
RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.

Who cannot join

Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder.
Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
Interventional/surgical procedures within 30 days prior to the Alterra or valve implant procedure

Show all 14Show fewer

Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the Alterra or valve implant procedure
History of or current intravenous drug use
Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
Known hypersensitivity to nitinol, cobalt-chromium, nickel or contrast media that cannot be adequately pre-medicated
Currently participating in an investigational drug or another device study [Note: Trials requiring extended follow up for products that were investigational, but have since become commercially available, are not considered investigational devices.]
Positive urine or serum pregnancy test in female patients of child-bearing potential
Renal insufficiency (creatinine > 3.0 mg/dL) and/or renal replacement therapy

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

United States14 sites

Emory University/ Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
University of Virgina
Charlottesville, Virginia, 22908
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
Children's Health Dallas
Dallas, Texas, 75235
Texas Children's Hospital
Houston, Texas, 77030
Cedars-Sinai Medical Center
Los Angeles, California, 90048
University of California, Los Angeles
Los Angeles, California, 90095
Columbia University Medical Center
New York, New York, 10032
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
University of California, San Francisco
San Francisco, California, 94122
Seattle Children's Hospital
Seattle, Washington, 98105
St. Louis Children's Hospital
St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Conditions: Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
Being tested: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
Medical subject headings: Lung Diseases, Tetralogy of Fallot, Heart Defects, Congenital, Pulmonary Valve Insufficiency

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 THVDevice
The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.

Study groups in NCT03130777
Study group	Role	What they receive
TPVR - Main Cohort	Experimental	Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System. Receives: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV
TPVR - PDS Registry	Experimental	Implantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS). Receives: Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THV

What is being measured

The primary outcome is the main question the study is designed to answer.

Main Cohort: THV Dysfunction
Number of patients with THV dysfunction, defined as a non-hierarchical composite of:
- RVOT/PV Reintervention
- Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE)
- Mean RVOT/PV Gradient >= 35mmHg via TTE
Measured: 6 months
PDS Registry: Acute PDS Success
Number of patients with acute PDS success, defined as a non-hierarchical composite of:
- Single THV implanted in the desired location
- Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient < 35 mmHg post-THV implantation
- Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE)
- Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation
Measured: 24 hours

Secondary outcomes (1)

Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
Number of patients with improvement in total pulmonary regurgitation
Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Aug 2017Jun 2032

First posted26 Apr 2017
Study start22 Aug 2017
Primary completion14 Jul 2022
Study completionJun 2032 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary DiseaseStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Model description: Single arm, prospective, multi-center study
Masking: None (open label)
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03130777
Sponsor's protocol ID: 2016-04
Status last verified: Oct 2026
First submitted: 24 Apr 2017
Last updated: 20 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Torres AJ, Dimas VV, Shahanavaz S, Balzer D, Morgan G, Lim DS, Armstrong AK, Berman D, Babaliaros V, Kim D, Gillespie MJ, Sommer R, Aboulhosn J, Jones TK, Mahadevan VS, Stapleton G, Ma Y, Shirali G, Parthiban A, Blanke P, Leipsic J, Zahn E. Transcatheter Pulmonary Valve Implantation With the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: 3-Year Pooled Outcomes of the ALTERRA Trials. Circ Cardiovasc Interv. 2026 Apr;19(4):e015873. doi: 10.1161/CIRCINTERVENTIONS.125.015873. Epub 2026 Feb 9.
PubMed 41657206

Study at a glance

From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multicenter Study of Congenital Pulmonic Valve Dysfunction Studying the SAPIEN 3 THV With the Alterra Adaptive Prestent
ClinicalTrials.gov ID: NCT03130777
Acronym / sponsor ID: 2016-04
Conditions: Pulmonary Disease, Transcatheter Pulmonary Valve Replacement (TPVR), Tetralogy of Fallot, Congenital Heart Disease, Pulmonary Regurgitation
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 86 participants (actual)
Lead sponsor: Edwards LifesciencesIndustry (pharma, biotech, devices)
Study start: 22 Aug 2017 (actual)
Primary completion: 14 Jul 2022 (actual)
Study completion: Jun 2032 (estimated)
First posted: 26 Apr 2017 (actual)
Results: Posted 8 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Following completion of enrollment, subjects will be eligible for enrollment in the continued access phase of the trial.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2
Model description: Single arm, prospective, multi-center study

Arm	Type	Receives
TPVR - Main Cohort	Experimental	Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THVImplantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Commander Delivery System.
TPVR - PDS Registry	Experimental	Device: Edwards Alterra Adaptive Prestent with SAPIEN 3 THVImplantation of Edwards Alterra Adaptive Prestent and Edwards SAPIEN 3 THV using Pulmonic Delivery System (PDS).

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

The candidate/candidate's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Weight is ≥ 20 kg (44 lbs).
RVOT/PV with moderate or greater PR by TTE.
RVOT/PV proximal and distal landing zone diameter ≥ 27 mm and ≤ 38 mm, and minimum of 35 mm from contractile tissue to lowest pulmonary artery takeoff.

Key exclusion criteria (14 listed)

Active infection requiring current antibiotic therapy (if temporary illness, patient may be a candidate 2 weeks after discontinuation of antibiotics).
History of or active endocarditis (active treatment with antibiotics) within the past 180 days.
Leukopenia (WBC < 2000 cells/μL), anemia (Hgb < 7 g/dL), thrombocytopenia (platelets < 50,000 cells/μL) or any known blood clotting disorder.
Inappropriate anatomy for introduction and delivery of the Alterra Adaptive Prestent or the SAPIEN 3 THV.
Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty

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 THVThe Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.	Device	TPVR - Main Cohort, TPVR - PDS Registry

Primary outcome

Main Cohort: THV Dysfunction
Time frame: 6 months
Number of patients with THV dysfunction, defined as a non-hierarchical composite of: * RVOT/PV Reintervention * Moderate or greater total Pulmonic Regurgitation via Transthoracic Echocardiography (TTE) * Mean RVOT/PV Gradient >= 35mmHg via TTE
PDS Registry: Acute PDS Success
Time frame: 24 hours
Number of patients with acute PDS success, defined as a non-hierarchical composite of: * Single THV implanted in the desired location * Right ventricle to pulmonary artery (RV-PA) peak-to-peak gradient < 35 mmHg post-THV implantation * Less than moderate total pulmonary regurgitation by discharge TTE (or earliest evaluable TTE) * Free of SAPIEN 3 / Alterra explant at 24 hours post-implantation

1 secondary outcome

Main Cohort: Improvement in Total Pulmonary Regurgitation From Baseline
Time frame: 30 days

Results and safety

Results posted to the registry on 8 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
TPVR - Main Cohort	61	60
TPVR - PDS Registry	25	24

Primary outcome: Main Cohort: THV Dysfunction

Time frame: 6 months. Count of participants. Unit: Participants

Measure	TPVR - Main Cohort n = 59
Value	0

Population analysed: Valve implant population, 1 subject did not complete the 6 month follow up.

Primary outcome: PDS Registry: Acute PDS Success

Time frame: 24 hours. Count of participants. Unit: Participants

Measure	TPVR - PDS Registry n = 25
Value	22

Population analysed: Attempted implant population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TPVR - Main Cohort	8 of 61 (13.1%)	35 of 61 (57.4%)	0 of 61
TPVR - PDS Registry	5 of 25 (20%)	11 of 25 (44%)	1 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41657206Torres AJ, Dimas VV, Shahanavaz S, Balzer D, Morgan G, Lim DS, Armstrong AK, Berman D, Babaliaros V, Kim D, Gillespie MJ, Sommer R, Aboulhosn J, Jones TK, Mahadevan VS, Stapleton G, Ma Y, Shirali G, Parthiban A, Blanke P, Leipsic J, Zahn E. Transcatheter Pulmonary Valve Implantation With the Alterra Adaptive Prestent and SAPIEN 3 Transcatheter Heart Valve: 3-Year Pooled Outcomes of the ALTERRA Trials. Circ Cardiovasc Interv. 2026 Apr;19(4):e015873. doi: 10.1161/CIRCINTERVENTIONS.125.015873. Epub 2026 Feb 9.
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.

Evan Zahn, MD, FACC, FSCAI principal investigator

Cedars-Sinai Heart Institute

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 14 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 20 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 14 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?

Yes. Results are posted in the registry (first posted 8 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Main Cohort: THV Dysfunction (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03130777, which also lists 1 linked publication.

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 20 Oct 2026.