Hydra Registry - Italy Experience

Sponsor

Sahajanand Medical Technologies Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05956652

Collaborator

Clinica Di Montevergine (Other)

500

Enrollment

Locations

Anticipated Duration (Months)

125

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis	Device: Hydra Transcatheter Aortic Valve System

Detailed 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.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2029

Outcome Measures

Primary Outcome Measures

Cardiovascular mortality [30 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Fondazione Poliambulanza Istituto	Brescia	Italy	25124
2	Montevergine Clinic, Mercogliano, Italy	Mercogliano	Italy	83013
3	IRCCS Ospedale Galeazzi-Sant'Ambrogio	Milano	Italy	20157
4	Università degli studi di Padova	Padova	Italy	35122

Sponsors and Collaborators

Sahajanand Medical Technologies Limited
Clinica Di Montevergine

Investigators

Principal Investigator: Dr. Angelo Cioppa, Montevergine Clinic, Mercogliano, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sahajanand Medical Technologies Limited

ClinicalTrials.gov Identifier:

NCT05956652

Other Study ID Numbers:

Hydra-IT, V1.0, 02/03/2022

First Posted:

Jul 21, 2023

Last Update Posted:

Jul 21, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sahajanand Medical Technologies Limited

Aortic Valve Stenosis, TAVI, Hydra

Additional relevant MeSH terms:

Aortic Valve Stenosis

Study Results

No Results Posted as of Jul 21, 2023