NCT04548726 - Hemodynamic Matched Comparison of the Balloon-Expandable Transcatheter Heart Valves Myval and Sapien-3 for the Treatment of Aortic Stenosis | Biotech Hunter

Enrollment

416

Participants

Timeline

Start Date

June 1, 2018

Primary Completion Date

September 30, 2020

Study Completion Date

September 30, 2020

Conditions

Aortic Valve StenosisAortic Valve Regurgitation

Interventions

DEVICE

Sapien 3 Transcather Aortic Valve Implant

Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.

DEVICE

Myval Transcather Aortic Valve Implant

Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.

Trial Locations (6)

Policlinico Umberto I, Roma

Policlinico Universitario Agostino Gemelli, Roma

Policlinico San Donato, San Donato Milanese

Ospedale San Raffaele, Segrate

Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas de Gran Canaria

Hospital Clínico San Carlos, Madrid

All Listed Sponsors

lead

Ignacio J. Amat Santos

OTHER