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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
- ClinicalTrials.gov ID
- NCT06342635
- Acronym / sponsor ID
- HYD/DENMARK-001/2023
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Valve Stenosis, TAVI, Hydra
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sahajanand Medical Technologies LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Qmed Consulting A/S
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with severe aortic valve stenosis
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydra Transcatheter Aortic Valve (THV) SeriesThe Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position. | Device | – |
Primary outcome
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).
24 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Valve Stenosis, run by Sahajanand Medical Technologies Limited at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Ole De Backer (+4527605009, ole.debacker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary safety endpoint (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.