# Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement

> **NCT02202434** · NA · TERMINATED · sponsor: **Boston Scientific Corporation** · enrollment: 1425 (actual)

## Conditions studied

- Aortic Stenosis

## Interventions

- **DEVICE:** Lotus Valve System
- **DEVICE:** CoreValve/Evolut R Transcatheter Aortic Valve Replacement System
- **DEVICE:** LOTUS Edge Valve System

## Key facts

- **NCT ID:** NCT02202434
- **Lead sponsor:** Boston Scientific Corporation
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2014-09-22
- **Primary completion:** 2017-03-08
- **Final completion:** 2021-05-21
- **Target enrollment:** 1425 (ACTUAL)
- **Why stopped:** RCT/Roll-in completed. CAS/21mm/Nested Registry terminated (investigational device is no longer available)
- **Last updated:** 2021-12-17


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT02202434

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT02202434, "Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT02202434. Licensed CC0.

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