Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
Location status: Recruiting
Location contact
Dr. Ole De Backer
CONTACT
Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06342635
Hydra Single-centre Experience - Copenhagen, Denmark
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–99 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥ 18 years
- Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
- Full understanding and willing to provide informed consent to study enrolment
Exclusion criteria
- Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
- Refusal to provide informed consent to study enrolment
- Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
- Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator
Treatment and study plan
Hydra transcatheter aortic valve (THV) series
DeviceThe Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Primary outcomes
-
Primary safety endpoint
Time frame: 30 days
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.
-
Primary performance endpoint
Time frame: 30 days
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).
Secondary outcomes
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Sahajanand Medical Technologies Limited
Industry
Collaborators
- Qmed Consulting A/S
Registry information
Official study title
Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Important dates
- Study start
- 2024
- Primary completion
- 2027
- Study completion
- 2027
- First posted
- Apr 2, 2024
- Registry last updated
- Apr 27, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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