# Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

> **NCT05804903** · NA · SUSPENDED · sponsor: **NVT GmbH** · enrollment: 177 (estimated)

## Conditions studied

- Transcatheter Aortic Valve Implantation

## Interventions

- **DEVICE:** (ALLEGRA Plus Transcatheter Heart Valve) TAVI in severe calcified aortic stenosis or in failed surgical aortic bioprosthesis

## Key facts

- **NCT ID:** NCT05804903
- **Lead sponsor:** NVT GmbH
- **Sponsor class:** INDUSTRY
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** SUSPENDED
- **Start date:** 2023-11-24
- **Primary completion:** 2025-08-31
- **Final completion:** 2030-08-01
- **Target enrollment:** 177 (ESTIMATED)
- **Why stopped:** Interim analysis showed ALLEGRA Plus did not provide clinically meaningful benefit over the CE-marked ALLEGRA THV System. Sponsor discontinued ALLEGRA Plus as a standalone product. Not terminated for safety reasons.
- **Last updated:** 2026-03-09


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05804903

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05804903, "Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis". Retrieved via AI Analytics 2026-06-24 from https://api.ai-analytics.org/clinical/NCT05804903. Licensed CC0.

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