Aortic Valve StenosisNCT06342635
Hydra Single-centre Experience - Copenhagen, Denmark
An observational study of Aortic Valve Stenosis, run by Sahajanand Medical Technologies Limited at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Hydra Transcatheter Aortic Valve (THV) Series
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jun 2024to 31 Oct 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with severe aortic valve stenosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen
Dr. Ole De Backer
Dr. Ole De Backer, Copenhagen University Hospital, Rigshospitalet
About this study
Official title: Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Hydra Transcatheter Aortic Valve (THV) Series
- Keywords
- Aortic Valve Stenosis, TAVI, Hydra
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra Transcatheter Aortic Valve (THV) SeriesDevice
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 30 days
Secondary outcomes (24)
Technical success
Measured: Immediately after procedure
Cardiovascular mortality
Measured: 30 days, and 1-year
All-cause mortality
Measured: 30 days, and 1-year
All stroke
Measured: 30 days, and 1-year
Disabling stroke
Measured: 30 days, and 1-year
Myocardial infarction
Measured: 30 days, and 1-year
Major vascular complication
Measured: 30 days
Acute kidney injury
Measured: 30 days
New permanent pacemaker implantation due to procedure related conduction abnormalities
Measured: 30 days, and 1-year
New-onset atrial fibrillation
Measured: 30 days, and 1-year
Coronary artery obstruction requiring intervention
Measured: 30 days, and 1-year
Re-hospitalization for procedure- or valve-related causes
Measured: 30 days, and 1-year
Mean aortic valve gradient
Measured: 30 days, and 1-year
Effective Orifice Area (EOA)
Measured: 30 days, and 1-year
Paravalvular leak
Measured: 30 days, and 1-year
New York Heart Association (NYHA) functional class
Measured: 30 days, and 1-year
Quality-of-life evaluation
Measured: 30 days, and 1-year
Bioprosthetic Valve Failure (BVF)
Measured: 30 days, and 1-year
Bioprosthetic valve dysfunction (BVD)
Measured: 30 days, and 1-year
Stroke or peripheral embolism
Measured: 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
Measured: 30 days, and 1-year
Rates of Hypoattenuated Leaflet Thickening (HALT)
Measured: 30 days
Rates of Reduced leaflet motion (RLM)
Measured: 30 days
Commissural alignment
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start18 Jun 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Sahajanand Medical Technologies Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Qmed Consulting A/S
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342635
- Sponsor's protocol ID
- HYD/DENMARK-001/2023
- Status last verified
- Apr 2026
- First submitted
- 21 Mar 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No