MedTrace Logo

Hydra Single-centre Experience - Copenhagen, Denmark

NCT06342635 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-27

No results posted yet for this study

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.

Conditions

  • Aortic Valve Stenosis

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.

Sponsors & Collaborators

  • Qmed Consulting A/S

    collaborator INDUSTRY

  • Sahajanand Medical Technologies Limited

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-18
Primary Completion
2027-09-30
Completion
2027-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06342635 on ClinicalTrials.gov