Hydra Single-centre Experience - Copenhagen, Denmark
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hydra Transcatheter Aortic Valve (THV) Series.
- Who it may be relevant to
- Registry conditions: Aortic Valve Stenosis. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
Overview
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.
Interventions
- Device Hydra Transcatheter Aortic Valve (THV) Series
The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.
Primary outcome measures
- Primary safety endpoint [Time frame: 30 days]
- Primary performance endpoint [Time frame: 30 days]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Denmark · 1 center
- Copenhagen University Hospital, Rigshospitalet — Copenhagen
Identifiers
NCT: NCT06342635 · HYD/DENMARK-001/2023