NCT07566624

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
33mo left

Started Jun 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 5, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

2.6 years

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Severe Aortic Valve StenosisValvular Heart DiseaseAortic Valve Stenosis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (46)

  • All cause mortality

    7 days

  • All cause mortality

    30 days

  • All cause mortality

    12 months

  • Cardiovascular mortality

    7 days

  • Cardiovascular mortality

    30 days

  • +41 more secondary outcomes

Study Arms (1)

Hydra Transcatheter Heart Valve (THV)

Device: Hydra THV

Interventions

Hydra THVDEVICE

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

Hydra Transcatheter Heart Valve (THV)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 41049310BACKGROUND

  • 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.

    PMID: 34991828BACKGROUND

  • 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.

    PMID: 41819447BACKGROUND

  • 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.

    PMID: 41672766BACKGROUND

  • 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.

    PMID: 40878295BACKGROUND

MeSH Terms

Conditions

Aortic Valve StenosisHeart Valve Diseases

Condition Hierarchy (Ancestors)

Aortic Valve DiseaseHeart DiseasesCardiovascular DiseasesVentricular Outflow Obstruction

Central Study Contacts

RAUL MORENO GOMEZ, MD, PhD

CONTACT

0034917277000raulmorenog@hotmail.com

FUNDACION EPIC

CONTACT

0034987876135iepic@fundacionepic.org

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 5, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

February 1, 2029

Last Updated

May 5, 2026

Record last verified: 2026-04