# SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial

> **NCT04722250** · NA · ACTIVE_NOT_RECRUITING · sponsor: **Medtronic Cardiovascular** · enrollment: 1103 (actual)

## Conditions studied

- Symptomatic Aortic Stenosis
- Aortic Valve Stenosis
- Aortic Valve Replacement

## Interventions

- **DEVICE:** Medtronic Evolut PRO, Evolut PRO+ or Evolut FX (where commercially available) TAV Systems
- **DEVICE:** Edwards SAPIEN 3 or SAPIEN 3 Ultra THV Systems

## Key facts

- **NCT ID:** NCT04722250
- **Lead sponsor:** Medtronic Cardiovascular
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-04-02
- **Primary completion:** 2023-11-10
- **Final completion:** 2027-12
- **Target enrollment:** 1103 (ACTUAL)
- **Last updated:** 2026-02-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04722250

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04722250, "SMall Annuli Randomized To Evolut™ or SAPIEN™ Trial". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT04722250. Licensed CC0.

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