An observational study in Aortic Valve Stenosis, sponsored by Sahajanand Medical Technologies Limited. Withdrawn at 4 sites in Italy. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Sahajanand Medical Technologies Limited · Observational
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.
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.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
Browse Aortic Valve Stenosis studies →Sahajanand Medical Technologies Limited is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient with severe aortic valve stenosis
Exclusion Criteria:
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.
Cardiovascular mortality
Time frame: 30 days
All-cause mortality
Cardiovascular mortality, valve-related mortality, and non-cardiovascular mortality
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
All stroke
Disabling and non-disabling stroke
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Disabling stroke
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Myocardial infarction
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Life-threatening or disabling bleeding
Time frame: 30 days
Major vascular complications
Time frame: 30 days
Acute kidney injury (Stage 2 or 3)
Time frame: 30 days
New permanent pacemaker implantation (PPM)
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Paravalvular Leak (PVL)
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Effective Orifice Area (EOA)
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Mean aortic valve gradient
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
New York Heart Association (NYHA) functional classification
Time frame: 30 days, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Sahajanand Medical Technologies Limited