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Monitoring outcomes of a new heart valve system in patients with pulmonary valve issues

Multicenter Post-Approval Study of Congenital Pulmonic Valve Dysfunction Studying the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System With Alterra Adaptive Prestent

Observational Edwards Lifesciences · NCT05378386

This study is testing a new heart valve system to see how well it works and keeps patients with severe pulmonary valve problems healthy after it's implanted.

Quick facts

Study typeObservational
Enrollment150 (estimated)
SexAll
SponsorEdwards Lifesciences Industry-sponsored
Locations22 sites (Birmingham, Alabama and 21 other locations)
Trial IDNCT05378386 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the performance and outcomes of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System combined with the Alterra Adaptive Prestent in patients with severe pulmonary regurgitation or other related heart defects. It is a single-arm, prospective, multicenter study that will collect data on device effectiveness and safety in a real-world setting following its approval. Participants will be monitored for their clinical outcomes post-implantation to gather valuable insights into the device's long-term performance.

Who should consider this trial

Good fit: Ideal candidates include individuals with severe pulmonary regurgitation who are clinically indicated for pulmonary valve replacement and are planned for treatment with the Alterra prestent and SAPIEN 3 valve.

Not a fit: Patients who cannot tolerate anticoagulation or have active infections such as bacterial endocarditis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with pulmonary valve insufficiency and related heart conditions.

How similar studies have performed: Other studies involving transcatheter pulmonary valve replacement have shown promising results, indicating that this approach is gaining traction in clinical practice.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Native or surgically-repaired RVOT with severe PR
2. Clinically indicated for pulmonary valve replacement
3. Planned for treatment with the Alterra prestent and SAPIEN 3 THV

Exclusion Criteria:

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis or other active infections

Where this trial is running

Birmingham, Alabama and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary Valve InsufficiencyComplex Congenital Heart DefectTetralogy of FallotPulmonary RegurgitationRVOT AnomalyAlterra prestentSAPIEN 3Pulmonic Delivery System
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.