Hydra Registry - Italy Experience

Launched by SAHAJANAND MEDICAL TECHNOLOGIES LIMITED · Jul 14, 2023

Keywords

ClinConnect Summary

The Hydra Registry - Italy Experience is a study designed to gather information about a treatment called the Hydra TAVI System for patients with a serious heart condition known as aortic valve stenosis. This condition happens when the heart's aortic valve becomes narrowed, making it hard for blood to flow. The study aims to learn more about how well this treatment works in the short, medium, and long term. It is currently looking for participants, specifically adults aged between 65 and 74, who are experiencing severe symptoms related to this heart condition and are considered suitable candidates for the TAVI procedure by a medical team.

To join the study, participants must be able to understand and agree to take part. However, those who have certain medical issues that would make the TAVI procedure unsafe, or who might not be able to keep up with follow-up appointments, cannot participate. If eligible, participants can expect to provide some information about their health before the procedure and will be monitored over time to see how well they are doing after receiving the treatment. This study is important because it aims to improve our understanding of the Hydra TAVI System and its effectiveness for people with aortic valve stenosis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with severe symptomatic native aortic valve stenosis and candidates for the TAVI procedure based on the evaluation of the Heart Team
• • Ability to understand and provide informed consent for inclusion in the study
• Exclusion Criteria:
• • Contraindication to TAVI: e.g. evidence of intracardiac mass, thrombus or vegetation, endocarditis.
• • Refusal by the patient to participate in the study
• • High probability of non-adherence to required follow-ups