# Optimize PRO Study

> **NCT04091048** · — · COMPLETED · sponsor: **Medtronic Cardiovascular** · enrollment: 1127 (actual)

## Conditions studied

- Symptomatic Aortic Stenosis

## Interventions

- **DEVICE:** Evolut™ PRO and Evolut™ PRO+ System (Evolut™ FX System for the addendum)

## Key facts

- **NCT ID:** NCT04091048
- **Lead sponsor:** Medtronic Cardiovascular
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2019-09-16
- **Primary completion:** 2023-12-15
- **Final completion:** 2024-11-13
- **Target enrollment:** 1127 (ACTUAL)
- **Last updated:** 2026-01-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04091048

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04091048, "Optimize PRO Study". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT04091048. Licensed CC0.

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