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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.
Assessment of the success rate of implantation
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
Time frame: 7 days
Success of the procedure
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.
Time frame: 7 days
All cause mortality
Incidence of all cause mortality
Time frame: 7 days
All cause mortality
Incidence of all cause mortality
Time frame: 30 days
All cause mortality
Incidence of all cause mortality
Time frame: 12 months
Cardiovascular mortality
Incidence of cardiovascular mortality
Time frame: 7 days
Cardiovascular mortality
Incidence of cardiovascular mortality
Time frame: 30 days
Cardiovascular mortality
Incidence of cardiovascular mortality
Time frame: 12 months
Stroke
Incidence of Stroke
Time frame: 7 days
Stroke
Incidence of Stroke
Time frame: 30 days
Stroke
Incidence of Stroke
Time frame: 12 months
Stroke with disabling
Incidence of Stroke with disabling
Time frame: 7 days
Stroke with disabling
Incidence of Stroke with disabling
Time frame: 30 days
Stroke with disabling
Incidence of Stroke with disabling
Time frame: 12 months
Stroke with non disabling
Incidence of Stroke with non disabling
Time frame: 7 days
Stroke with non disabling
Incidence of Stroke with non disabling
Time frame: 30 days
Stroke with non disabling
Incidence of Stroke with non disabling
Time frame: 12 months
Acute myocardial infarction
Incidence of acute myocardial infarction
Time frame: 7 days
Acute myocardial infarction
Incidence of acute myocardial infarction
Time frame: 30 days
Acute myocardial infarction
Incidence of acute myocardial infarction
Time frame: 12 months
Coronary occlusion
Incidence of coronary occlusion
Time frame: 7days
Coronary occlusion
Incidence of coronary occlusion
Time frame: 30 days
Coronary occlusion
Incidence of coronary occlusion
Time frame: 12 months
Haemorrhagic complications
Incidence of haemorrhagic complications
Time frame: 7 days
Haemorrhagic complications
Incidence of haemorrhagic complications
Time frame: 30 days
Haemorrhagic complications
Incidence of haemorrhagic complications
Time frame: 12 months
Vascular complications
Incidence of vascular complications
Time frame: 7 days
Vascular complications
Incidence of vascular complications
Time frame: 30 days
Vascular complications
Incidence of vascular complications
Time frame: 12 Months
Acute renal failure
Incidence of Acute renal failure
Time frame: 7 days
Acute renal failure
Incidence of Acute renal failure
Time frame: 30 days
Acute renal failure
Incidence of Acute renal failure
Time frame: 12 months
Conduction disturbances
Incidence of conduction disturbances
Time frame: 7 days
Conduction disturbances
Incidence of conduction disturbances
Time frame: 30 days
Conduction disturbances
Incidence of conduction disturbances
Time frame: 12 months
Arrhythmias
Incidence of Arrhythmias
Time frame: 7 days
Arrhythmias
Incidence of Arrhythmias
Time frame: 30 days
Arrhythmias
Incidence of Arrhythmias
Time frame: 12 months
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Time frame: 7 days
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Time frame: 30 days
Implantation of a new permanent pacemaker
Incidence of Implantation of a new permanent pacemaker
Time frame: 12 months
Combined safety event at 30 days defined by Valve Academic Research Consortium 3 (VARC-3) criteria
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.
Time frame: 30 days
New York Heart Association (NYHA)
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
Time frame: 7 days
New York Heart Association (NYHA)
Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure
Time frame: 30 days
New York Heart Association (NYHA)
Proportion of patients with modification of NYHA before the procedure and its modification after the procedure
Time frame: 12 months
Echocardiographic Valve Dysfunction Assessment
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
Time frame: 7 days
Echocardiographic Valve Dysfunction Assessment
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
Time frame: 30 days
Echocardiographic Valve Dysfunction Assessment
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
Time frame: 12 months
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