# Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement

> **NCT01675440** · — · COMPLETED · sponsor: **Medtronic Cardiovascular** · enrollment: 782 (actual)

## Conditions studied

- Severe Aortic Stenosis

## Interventions

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

## Key facts

- **NCT ID:** NCT01675440
- **Lead sponsor:** Medtronic Cardiovascular
- **Sponsor class:** INDUSTRY
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** COMPLETED
- **Start date:** 2012-08
- **Primary completion:** 2016-12
- **Final completion:** 2025-04-08
- **Target enrollment:** 782 (ACTUAL)
- **Last updated:** 2026-05-05


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01675440

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01675440, "Safety & Efficacy Study of the Medtronic CoreValve® System-Treatment of Symptomatic Severe Aortic Stenosis With Significant Comorbidities in Extreme Risk Subjects Who Need Aortic Valve Replacement". Retrieved via AI Analytics 2026-06-05 from https://api.ai-analytics.org/clinical/NCT01675440. Licensed CC0.

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