Aortic Valve Stenosis, Severe Aortic Valve Stenosis, Valvular Heart Disease
Conditions
Brief summary
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system. The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
Detailed description
This study is designed to evaluate the success rate of transfemoral implantation of the Hydra THV biological aortic valve prosthesis in patients with severe symptomatic aortic stenosis. The device is used in accordance with its Instructions for Use as a CE-marked transcatheter heart valve system. The study will assess procedural success, device performance, and early clinical outcomes following implantation. Patients undergoing transcatheter aortic valve replacement (TAVR) via the transfemoral approach will be followed to evaluate safety and effectiveness outcomes, including short- and mid-term clinical follow-up.
Interventions
DEVICEHydra THV
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
Sponsors
Fundación EPIC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants who meet ALL of the following conditions will be included: * Age ≥ 18 years and; * Severe aortic stenosis with indication for aortic valve replacement in which a Hydra THV device is implanted according to the instructions for use; and * Signed informed consent.
Exclusion criteria
Patients who do NOT meet ANY of the following conditions will be included: * Express refusal by the participant to participate in the study. * Aortic stenosis patients who are not candidates for Hydra THV device implantation or in whom implantation of this device is performed for an indication other than aortic stenosis (especially pure native aortic valve insufficiency). Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses may be included in the study. * Participants in randomised clinical trials who have not reached the research endpoint. * Pregnant and/or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the success rate of implantation | 7 days | Assessment of the success rate of implantation defined by: * Absence of mortality during the procedure or within 24 hours after implantation; and * Correct anatomical positioning of a single valve; and * Absence of mismatch, defined as effective aortic valve area \> 0.85 cm²/m²and; * Mean gradient \< 20 mm Hg or peak velocity \< 3 m/s and; * Absence of moderate or severe aortic regurgitation |
| Success of the procedure | 7 days | Composite outcome measures defined as a the absence of intra-procedural mortality or complications during implantation, such as: failure to implant the valve at the annulus level, the need to implant more than one valve (valve-in-valve implantation or implantation of a second valve due to embolisation of the first) or surgical intervention on the aortic valve due to severe aortic insufficiency or complications of the procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | 7 days | Incidence of all cause mortality |
| Cardiovascular mortality | 7 days | Incidence of cardiovascular mortality |
| Stroke | 7 days | Incidence of Stroke |
| Stroke with disabling | 7 days | Incidence of Stroke with disabling |
| Stroke with non disabling | 7 days | Incidence of Stroke with non disabling |
| Acute myocardial infarction | 7 days | Incidence of acute myocardial infarction |
| Coronary occlusion | 7days | Incidence of coronary occlusion |
| Haemorrhagic complications | 7 days | Incidence of haemorrhagic complications |
| Vascular complications | 7 days | Incidence of vascular complications |
| Acute renal failure | 7 days | Incidence of Acute renal failure |
| Conduction disturbances | 7 days | Incidence of conduction disturbances |
| Arrhythmias | 7 days | Incidence of Arrhythmias |
| Implantation of a new permanent pacemaker | 7 days | Incidence of Implantation of a new permanent pacemaker |
| Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria | 30 days | Proportion of patients with freedom from: all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device. |
| New York Heart Association (NYHA) | 7 days | Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure |
| Echocardiographic Valve Dysfunction Assessment | 7 days | Composite outcome measures defined as a: Effective aortic valve area and Mean transvalvular gradient and Degree of aortic regurgitation and Left ventricular ejection fraction (LVEF) and Pulmonary systolic pressure. Any of the following findings are considered evidence of dysfunction: Mean gradient ≥ 20 mmHg. Effective aortic valve area ≤ 0.9-1.1 cm2/m2. Moderate or severe para-valvular insufficiency |
Countries
Spain
Contacts
CONTACTRAUL MORENO GOMEZ, MD, PhD
CONTACTFUNDACION EPIC
Outcome results
None listed