# PULSTA Transcatheter Pulmonary Valve Pre-Approval Study

> **NCT03983512** · NA · ACTIVE_NOT_RECRUITING · sponsor: **Taewoong Medical Co., Ltd.** · enrollment: 58 (estimated)

## Conditions studied

- Heart Diseases
- Pulmonary Valve Regurgitation
- Pulmonary Valve Stenosis
- Tetralogy of Fallot

## Interventions

- **DEVICE:** PULSTA TPV System

## Key facts

- **NCT ID:** NCT03983512
- **Lead sponsor:** Taewoong Medical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2019-10-07
- **Primary completion:** 2022-09-21
- **Final completion:** 2026-12
- **Target enrollment:** 58 (ESTIMATED)
- **Last updated:** 2026-04-13

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03983512

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03983512, "PULSTA Transcatheter Pulmonary Valve Pre-Approval Study". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT03983512. Licensed CC0.

---

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