# Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement

> **NCT01240902** · NA · COMPLETED · sponsor: **Medtronic Cardiovascular** · enrollment: 1453 (actual)

## Conditions studied

- Severe Aortic Stenosis

## Interventions

- **DEVICE:** Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
- **DEVICE:** Surgical Aortic Valve Replacement (SAVR)

## Key facts

- **NCT ID:** NCT01240902
- **Lead sponsor:** Medtronic Cardiovascular
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2010-12-10
- **Primary completion:** 2014-08
- **Final completion:** 2019-05-15
- **Target enrollment:** 1453 (ACTUAL)
- **Last updated:** 2022-10-25


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01240902

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01240902, "Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01240902. Licensed CC0.

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