TAVI with Hydra Valve for Aortic Valve Stenosis
Hydra Single-centre Experience - Copenhagen, Denmark
Recruiting
Observational Study
Aortic Valve Stenosis
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 – 99
- Sex
- Any
- Study type
- Observational
- Participants needed
- 50 (estimated)
- Sponsor
- Sahajanand Medical Technologies Limited · Industry
Who this trial is looking for
This trial is looking for patients with severe aortic stenosis who are considering a procedure called TAVI. Participants will receive a specific type of heart valve and will be followed for up to a year to see how it works and if there are any safety concerns.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old
- I have been diagnosed with severe aortic stenosis
- I understand the study and agree to participate
You may not be able to join if
- I have conditions that prevent me from having TAVI
- I refuse to give my consent to join the study
- I have severe aorta or artery disease
- I have significant calcification in my heart structure
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 trans…
Trial Locations
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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 (…
Contacts