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RECRUITING
NCT06342635

Hydra Single-centre Experience - Copenhagen, Denmark

Sponsor: Sahajanand Medical Technologies Limited

View on ClinicalTrials.gov

Summary

The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.

Official title: Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

OBSERVATIONAL

Enrollment

50

Start Date

2024-06-18

Completion Date

2026-10-31

Last Updated

2024-07-05

Healthy Volunteers

No

Interventions

DEVICE

Hydra Transcatheter Aortic Valve (THV) Series

The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Locations (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark