Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation

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.

No informado en este registro.

Device: Hydra THV

Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

Plazo: 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

Plazo: 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.

Plazo: 7 days

Incidence of all cause mortality

Plazo: 30 days

Incidence of all cause mortality

Plazo: 12 months

Incidence of all cause mortality

Plazo: 7 days

Incidence of cardiovascular mortality

Plazo: 30 days

Incidence of cardiovascular mortality

Plazo: 12 months

Incidence of cardiovascular mortality

Plazo: 7 days

Incidence of Stroke

Plazo: 30 days

Incidence of Stroke

Plazo: 12 months

Incidence of Stroke

Plazo: 7 days

Incidence of Stroke with disabling

Plazo: 30 days

Incidence of Stroke with disabling

Plazo: 12 months

Incidence of Stroke with disabling

Plazo: 7 days

Incidence of Stroke with non disabling

Plazo: 30 days

Incidence of Stroke with non disabling

Plazo: 12 months

Incidence of Stroke with non disabling

Plazo: 7 days

Incidence of acute myocardial infarction

Plazo: 30 days

Incidence of acute myocardial infarction

Plazo: 12 months

Incidence of acute myocardial infarction

Plazo: 7days

Incidence of coronary occlusion

Plazo: 30 days

Incidence of coronary occlusion

Plazo: 12 months

Incidence of coronary occlusion

Plazo: 7 days

Incidence of haemorrhagic complications

Plazo: 30 days

Incidence of haemorrhagic complications

Plazo: 12 months

Incidence of haemorrhagic complications

Plazo: 7 days

Incidence of vascular complications

Plazo: 30 days

Incidence of vascular complications

Plazo: 12 Months

Incidence of vascular complications

Plazo: 7 days

Incidence of Acute renal failure

Plazo: 30 days

Incidence of Acute renal failure

Plazo: 12 months

Incidence of Acute renal failure

Plazo: 7 days

Incidence of conduction disturbances

Plazo: 30 days

Incidence of conduction disturbances

Plazo: 12 months

Incidence of conduction disturbances

Plazo: 7 days

Incidence of Arrhythmias

Plazo: 30 days

Incidence of Arrhythmias

Plazo: 12 months

Incidence of Arrhythmias

Plazo: 7 days

Incidence of Implantation of a new permanent pacemaker

Plazo: 30 days

Incidence of Implantation of a new permanent pacemaker

Plazo: 12 months

Incidence of Implantation of a new permanent pacemaker

Plazo: 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.

Plazo: 7 days

Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure

Plazo: 30 days

Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure

Plazo: 12 months

Proportion of patients with modification of NYHA before the procedure and its modification after the procedure

Plazo: 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

Plazo: 30 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

Plazo: 12 months

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

Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation