Hydra Registry - Italy Experience

Aortic Valve Stenosis Clinical Trial

Official title:

Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956652
• Other study ID #: Hydra-IT, V1.0, 02/03/2022
• Status: Recruiting
• Start date: July 1, 2023
• Est. completion date: July 31, 2029

Study information

• Verified date: February 2024
• Source: Sahajanand Medical Technologies Limited
• Contact: Dr. Angelo Cioppa
• Phone: +390825705131
• Email: emodinamica[@]clinicamontevergine.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Hydra-IT is a multicenter observational study aim to collect clinical, procedural and follow-up data and evaluate the short, medium and long term results of Hydra TAVI System in patient with severe aortic stenosis.

Description:

Hydra-IT is a multicenter observational study conducted across different centres in Italy. The primary objective of the study is to evaluate the safety and efficacy of transcatheter aortic valve implantation and clinical outcome in patients treated with Hydra device. Secondary objective is to evaluate the long term (up to 5 years) effectiveness and the quality of treatment using Hydra device. Patients with severe stenosis symptomatic of the native aortic valve or bioprosthesis in a degenerated aortic position will be included in this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2029
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Hydra Transcatheter Aortic Valve System
The Hydra device is self-expanding transcatheter aortic valve consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza Istituto	Brescia
Italy	Montevergine Clinic, Mercogliano, Italy	Mercogliano
Italy	IRCCS Ospedale Galeazzi-Sant'Ambrogio	Milano
Italy	Università degli studi di Padova	Padova

Sponsors (2)

Lead Sponsor	Collaborator
Sahajanand Medical Technologies Limited	Clinica Di Montevergine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular mortality		30 days
Secondary	All-cause mortality	Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	All stroke	Disabling and non-disabling stroke	30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Disabling stroke		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Myocardial infarction		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Life-threatening or disabling bleeding		30 days
Secondary	Major vascular complications		30 days
Secondary	Acute kidney injury (Stage 2 or 3)		30 days
Secondary	New permanent pacemaker implantation (PPM)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Paravalvular Leak (PVL)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Effective Orifice Area (EOA)		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	Mean aortic valve gradient		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Secondary	New York Heart Association (NYHA) functional classification		30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years