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

Phase

SUSPENDED

Status

177

Enrollment

INDUSTRY

Sponsor class

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.

Conditions

Transcatheter Aortic Valve Implantation

Interventions

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

Sponsor

NVT GmbH