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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydra Transcatheter Heart Valve (THV) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydra THV | Device | Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the success rate of implantation | Assessment of the success rate of implantation defined by:
| 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. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| All cause mortality | Incidence of all cause mortality | 7 days |
| All cause mortality | Incidence of all cause mortality | 30 days |
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Inclusion Criteria:
Participants who meet ALL of the following conditions will be included:
Exclusion Criteria:
Patients who do NOT meet ANY of the following conditions will be included:
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The Hydra THV valve is approved for the treatment of patients with aortic stenosis. Basically, patients will be eligible for inclusion in this clinical scenario, according to the instructions for use of the device.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| RAUL MORENO GOMEZ, MD, PhD | Contact | 0034917277000 | raulmorenog@hotmail.com | |
| FUNDACION EPIC | Contact | 0034987876135 | iepic@fundacionepic.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Fuencarral-El Pardo | 28046 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41049310 | Background | Senguttuvan NB, Jose J, Sonawane A, Bansal S, Gupta R, Chandra P. Clinical evaluation of the Hydra self-expanding THV: 30-day results from the GENESIS-II study. AsiaIntervention. 2025 Oct 10;11(3):155-163. doi: 10.4244/AIJ-D-24-00075. eCollection 2025 Oct. | |
| 34991828 | Background | Aidietis A, Srimahachota S, Dabrowski M, Bilkis V, Buddhari W, Cheung GSH, Nair RK, Mussayev AA, Mattummal S, Chandra P, Mahajan AU, Chmielak Z, Govindan SC, Jose J, Hiremath MS, Chandra S, Shetty R, Mohanan S, John JF, Mehrotra S, Sondergaard L. 30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study. JACC Cardiovasc Interv. 2022 Jan 10;15(1):93-104. doi: 10.1016/j.jcin.2021.09.004. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
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| All cause mortality | Incidence of all cause mortality | 12 months |
| Cardiovascular mortality | Incidence of cardiovascular mortality | 7 days |
| Cardiovascular mortality | Incidence of cardiovascular mortality | 30 days |
| Cardiovascular mortality | Incidence of cardiovascular mortality | 12 months |
| Stroke | Incidence of Stroke | 7 days |
| Stroke | Incidence of Stroke | 30 days |
| Stroke | Incidence of Stroke | 12 months |
| Stroke with disabling | Incidence of Stroke with disabling | 7 days |
| Stroke with disabling | Incidence of Stroke with disabling | 30 days |
| Stroke with disabling | Incidence of Stroke with disabling | 12 months |
| Stroke with non disabling | Incidence of Stroke with non disabling | 7 days |
| Stroke with non disabling | Incidence of Stroke with non disabling | 30 days |
| Stroke with non disabling | Incidence of Stroke with non disabling | 12 months |
| Acute myocardial infarction | Incidence of acute myocardial infarction | 7 days |
| Acute myocardial infarction | Incidence of acute myocardial infarction | 30 days |
| Acute myocardial infarction | Incidence of acute myocardial infarction | 12 months |
| Coronary occlusion | Incidence of coronary occlusion | 7days |
| Coronary occlusion | Incidence of coronary occlusion | 30 days |
| Coronary occlusion | Incidence of coronary occlusion | 12 months |
| Haemorrhagic complications | Incidence of haemorrhagic complications | 7 days |
| Haemorrhagic complications | Incidence of haemorrhagic complications | 30 days |
| Haemorrhagic complications | Incidence of haemorrhagic complications | 12 months |
| Vascular complications | Incidence of vascular complications | 7 days |
| Vascular complications | Incidence of vascular complications | 30 days |
| Vascular complications | Incidence of vascular complications | 12 Months |
| Acute renal failure | Incidence of Acute renal failure | 7 days |
| Acute renal failure | Incidence of Acute renal failure | 30 days |
| Acute renal failure | Incidence of Acute renal failure | 12 months |
| Conduction disturbances | Incidence of conduction disturbances | 7 days |
| Conduction disturbances | Incidence of conduction disturbances | 30 days |
| Conduction disturbances | Incidence of conduction disturbances | 12 months |
| Arrhythmias | Incidence of Arrhythmias | 7 days |
| Arrhythmias | Incidence of Arrhythmias | 30 days |
| Arrhythmias | Incidence of Arrhythmias | 12 months |
| Implantation of a new permanent pacemaker | Incidence of Implantation of a new permanent pacemaker | 7 days |
| Implantation of a new permanent pacemaker | Incidence of Implantation of a new permanent pacemaker | 30 days |
| Implantation of a new permanent pacemaker | Incidence of Implantation of a new permanent pacemaker | 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. | 30 days |
| New York Heart Association (NYHA) | Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure | 7 days |
| New York Heart Association (NYHA) | Proportion of patients with modification of NYHA, before the procedure and its modification after the procedure | 30 days |
| New York Heart Association (NYHA) | Proportion of patients with modification of NYHA before the procedure and its modification after the procedure | 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 | 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 | 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 | 12 months |
| 41819447 | Background | Sonawane A, Chandra P, Jose J, Bansal S, Gupta R, Sudhir K, Senguttuvan NB. Safety and performance of the Hydra self-expanding THV: 6 months outcomes from the GENESIS-II study. Indian Heart J. 2026 Mar 10:S0019-4832(26)00035-0. doi: 10.1016/j.ihj.2026.03.004. Online ahead of print. |
| 41672766 | Background | Marin-Cuartas M, Kawczynski MJ, de Waha S, Kiefer P, Falk V, Siepe M, Bowdish ME, Akowuah E, Verbrugghe P, Oosterlinck W, Klautz RJM, Lorusso R, Bidar E, Rahouma MM, Redfors B, Biondi-Zoccai G, Bhatt DL, Gaudino M, Borger MA, Heuts S. Updated 5-year outcomes of transcatheter versus surgical aortic valve replacement in patients with severe aortic stenosis at low- to intermediate-surgical risk. Heart. 2026 Feb 11:heartjnl-2025-327092. doi: 10.1136/heartjnl-2025-327092. Online ahead of print. |
| 40878295 | Background | Praz F, Borger MA, Lanz J, Marin-Cuartas M, Abreu A, Adamo M, Ajmone Marsan N, Barili F, Bonaros N, Cosyns B, De Paulis R, Gamra H, Jahangiri M, Jeppsson A, Klautz RJM, Mores B, Perez-David E, Poss J, Prendergast BD, Rocca B, Rossello X, Suzuki M, Thiele H, Tribouilloy CM, Wojakowski W; ESC/EACTS Scientific Document Group. 2025 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2025 Nov 21;46(44):4635-4736. doi: 10.1093/eurheartj/ehaf194. No abstract available. |