NCT06342635 Hydra Single-centre Experience - Copenhagen, Denmark
| NCT ID | NCT06342635 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sahajanand Medical Technologies Limited |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-06-18 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-06-18 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06342635 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06342635 currently recruiting?
Yes, NCT06342635 is actively recruiting participants. Contact the research team at ole.debacker@gmail.com for enrollment information.
Where is the NCT06342635 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT06342635 clinical trial?
NCT06342635 is sponsored by Sahajanand Medical Technologies Limited. The trial plans to enroll 50 participants.