Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07566624

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

Sponsor: Fundación EPIC

View on ClinicalTrials.gov

Summary

This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system. The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-07-07

Completion Date

2029-02-01

Last Updated

2026-08-05

Healthy Volunteers

No

Interventions

DEVICE

Hydra THV

Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

Locations (2)

Hospital Universitario La Paz

Fuencarral-El Pardo, Spain

Hospital Clínico Universitario de Santiago

Santiago de Compostela, Spain