Clinical trial NCT05956652: Hydra Registry - Italy Experience
Official title: Observational Study on the Efficacy and Safety of Transcatheter Implantation of Hydra Biological Aortic Prosthesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Valve Stenosis
Keywords: Aortic Valve Stenosis
TAVI
Hydra
Lead sponsor: Sahajanand Medical Technologies Limited
Sponsor class: INDUSTRY
Collaborators: name: Clinica Di Montevergine
First posted: 2023-07-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with severe aortic valve stenosis

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.

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.

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

Primary outcomes:
measure: Cardiovascular mortality
timeFrame: 30 days
Secondary outcomes:
measure: All-cause mortality
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: All stroke
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Disabling stroke
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Myocardial infarction
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Life-threatening or disabling bleeding
timeFrame: 30 days
measure: Major vascular complications
timeFrame: 30 days
measure: Acute kidney injury (Stage 2 or 3)
timeFrame: 30 days
measure: New permanent pacemaker implantation (PPM)
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Paravalvular Leak (PVL)
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Effective Orifice Area (EOA)
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Mean aortic valve gradient
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: New York Heart Association (NYHA) functional classification
timeFrame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Fondazione Poliambulanza Istituto
city: Mercogliano
country: Italy
facility: Montevergine Clinic, Mercogliano, Italy
city: Milano
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
city: Padova
country: Italy
facility: Università degli studi di Padova
Study officials:
affiliation: Montevergine Clinic, Mercogliano, Italy
name: Dr. Angelo Cioppa
role: PRINCIPAL_INVESTIGATOR
References: