Evaluating the Hydra valve for severe aortic stenosis in Copenhagen
Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve
This study is testing a new type of heart valve for people with severe aortic stenosis to see how well it works and if it causes any new heart rhythm problems after the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Sahajanand Medical Technologies Limited Industry-sponsored |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06342635 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of the Hydra transcatheter aortic valve (THV) series in patients with severe aortic stenosis over a one-year period following the procedure. It will also investigate the impact of valve geometry on the occurrence of new conduction abnormalities by analyzing post-operative CT scans one month after the transcatheter aortic valve replacement. The study involves patients who are eligible for the TAVI procedure as determined by a local Heart Team evaluation.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years and older with severe aortic stenosis who are eligible for the TAVI procedure.
Not a fit: Patients with contraindications to TAVI or those deemed unsuitable for the Hydra THV series will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes for patients with severe aortic stenosis by providing insights into the safety and efficacy of the Hydra valve.
How similar studies have performed: While this study focuses on a specific valve series, similar studies evaluating transcatheter aortic valve replacements have shown promising results in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation 3. Full understanding and willing to provide informed consent to study enrolment Exclusion Criteria: 1. Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis) 2. Refusal to provide informed consent to study enrolment 3. Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI 4. 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
Where this trial is running
Copenhagen
- Copenhagen University Hospital, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Dr. Ole De Backer
- Email: ole.debacker@gmail.com
- Phone: +4527605009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.