An observational study in Aortic Valve Stenosis, sponsored by Sahajanand Medical Technologies Limited. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-27.
Sponsored by Sahajanand Medical Technologies Limited · Observational
The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.
985 studies on the registry are indexed under Aortic Valve Stenosis; 283 are open to participants now.
This study's planned enrollment of 50 is below the median of 200 across 424 observational studies indexed under Aortic Valve Stenosis.
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 consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Primary safety endpoint
Early safety as defined by VARC-3, as composite of: * Freedom from all-cause mortality; * Freedom from all stroke; * Freedom from VARC 3 type 3-4 bleeding; * Freedom from major vascular, access-related, or cardiac structural complication; * Freedom from acute kidney injury stage 3 or 4; * Freedom from moderate or severe aortic regurgitation; * Freedom from new permanent pacemaker due to procedure-related conduction abnormalities; * Freedom from surgery or intervention related to the device.
Time frame: 30 days
Primary performance endpoint
Device success as defined by VARC-3, as composite of: * Technical success; * Freedom from mortality; * Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication; * Intended performance of the valve (mean gradient \<20mmHg, peak velocity \<3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).
Time frame: 30 days
Technical success
Time frame: Immediately after procedure
Cardiovascular mortality
Time frame: 30 days, and 1-year
All-cause mortality
Time frame: 30 days, and 1-year
All stroke
Time frame: 30 days, and 1-year
Disabling stroke
Time frame: 30 days, and 1-year
Myocardial infarction
Time frame: 30 days, and 1-year
Major vascular complication
Time frame: 30 days
Acute kidney injury
Time frame: 30 days
New permanent pacemaker implantation due to procedure related conduction abnormalities
Time frame: 30 days, and 1-year
New-onset atrial fibrillation
Time frame: 30 days, and 1-year
Coronary artery obstruction requiring intervention
Time frame: 30 days, and 1-year
Re-hospitalization for procedure- or valve-related causes
Time frame: 30 days, and 1-year
Mean aortic valve gradient
Time frame: 30 days, and 1-year
Effective Orifice Area (EOA)
Time frame: 30 days, and 1-year
Paravalvular leak
Time frame: 30 days, and 1-year
New York Heart Association (NYHA) functional class
Time frame: 30 days, and 1-year
Quality-of-life evaluation
Time frame: 30 days, and 1-year
Bioprosthetic Valve Failure (BVF)
Time frame: 30 days, and 1-year
Bioprosthetic valve dysfunction (BVD)
Time frame: 30 days, and 1-year
Stroke or peripheral embolism
Time frame: 30 days, and 1-year
VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns
Time frame: 30 days, and 1-year
Rates of Hypoattenuated Leaflet Thickening (HALT)
Time frame: 30 days
Rates of Reduced leaflet motion (RLM)
Time frame: 30 days
Commissural alignment
Time frame: 30 days
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Sahajanand Medical Technologies Limited