Spanish Prospective Registry of Hydra THV for Transcatheter Aortic Valve Implantation (HYSPANIA)

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 Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Stenosis; Valvular Heart Disease; Severe Aortic Valve Stenosis
• Intervention / Treatment: Device: Hydra THV

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: FUNDACION EPIC; Phone Number: 0034987876135; Email: iepic@fundacionepic.org
• Study Contact Backup: Name: RAUL MORENO GOMEZ, MD, PhD; Phone Number: 0034917277000; Email: raulmorenog@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hydra Transcatheter Heart Valve (THV)	Device: Hydra THV; Patients in whom the Hydra THV device is implanted to treat patients with degenerated aortic bioprostheses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiovascular mortality	Incidence of cardiovascular mortality	12 months
All cause mortality	Incidence of all cause mortality	7 days
All cause mortality	Incidence of all cause mortality	30 days
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
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

Collaborators and Investigators

• Sponsor: Fundación EPIC

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): February 1, 2029

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis; Heart Valve Diseases
• Other Study ID Numbers: rEpic22-HYSPANIA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No