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| Name | Class |
|---|---|
| Qmed Consulting A/S | INDUSTRY |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydra Transcatheter Aortic Valve (THV) Series | Device | The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary safety endpoint | Early safety as defined by VARC-3, as composite of:
| 30 days |
| Primary performance endpoint | Device success as defined by VARC-3, as composite of:
| 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Immediately after procedure | |
| Cardiovascular mortality | 30 days, and 1-year | |
| All-cause mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with severe aortic valve stenosis
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ole De Backer | Contact | +4527605009 | ole.debacker@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 30 days, and 1-year |
| All stroke | 30 days, and 1-year |
| Disabling stroke | 30 days, and 1-year |
| Myocardial infarction | 30 days, and 1-year |
| Major vascular complication | 30 days |
| Acute kidney injury | 30 days |
| New permanent pacemaker implantation due to procedure related conduction abnormalities | 30 days, and 1-year |
| New-onset atrial fibrillation | 30 days, and 1-year |
| Coronary artery obstruction requiring intervention | 30 days, and 1-year |
| Re-hospitalization for procedure- or valve-related causes | 30 days, and 1-year |
| Mean aortic valve gradient | 30 days, and 1-year |
| Effective Orifice Area (EOA) | 30 days, and 1-year |
| Paravalvular leak | 30 days, and 1-year |
| New York Heart Association (NYHA) functional class | 30 days, and 1-year |
| Quality-of-life evaluation | 30 days, and 1-year |
| Bioprosthetic Valve Failure (BVF) | 30 days, and 1-year |
| Bioprosthetic valve dysfunction (BVD) | 30 days, and 1-year |
| Stroke or peripheral embolism | 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 | 30 days, and 1-year |
| Rates of Hypoattenuated Leaflet Thickening (HALT) | 30 days |
| Rates of Reduced leaflet motion (RLM) | 30 days |
| Commissural alignment | 30 days |
| D014694 |
| Ventricular Outflow Obstruction |