# ALTERRA Post-Approval Study

> **NCT05378386** · — · ACTIVE_NOT_RECRUITING · sponsor: **Edwards Lifesciences** · enrollment: 150 (actual)

## Conditions studied

- Pulmonary Valve Insufficiency
- Complex Congenital Heart Defect
- Tetralogy of Fallot
- Pulmonary Regurgitation
- RVOT Anomaly

## Interventions

- **DEVICE:** Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System

## Key facts

- **NCT ID:** NCT05378386
- **Lead sponsor:** Edwards Lifesciences
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-05-12
- **Primary completion:** 2025-09-25
- **Final completion:** 2035-07
- **Target enrollment:** 150 (ACTUAL)
- **Last updated:** 2025-11-04


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05378386

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05378386, "ALTERRA Post-Approval Study". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT05378386. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*