# COMPASSION S3 Post-Approval Study

> **NCT04860765** · — · ACTIVE_NOT_RECRUITING · sponsor: **Edwards Lifesciences** · enrollment: 150 (actual)

## Conditions studied

- Complex Congenital Heart Defect
- Dysfunctional RVOT Conduit
- Pulmonary Valve Insufficiency
- Pulmonary Valve Degeneration
- Pulmonary Valve; Obstruction

## Interventions

- **DEVICE:** SAPIEN 3 THV

## Key facts

- **NCT ID:** NCT04860765
- **Lead sponsor:** Edwards Lifesciences
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-04-13
- **Primary completion:** 2030-08
- **Final completion:** 2030-08
- **Target enrollment:** 150 (ACTUAL)
- **Last updated:** 2026-02-03


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04860765

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04860765, "COMPASSION S3 Post-Approval Study". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT04860765. Licensed CC0.

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