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NCT Number: NCT06342635

Hydra Single-centre Experience - Copenhagen, Denmark

The present study aims to evaluate the efficacy and safety of TAVI using the Hydra transcatheter aortic valve (THV) series, in patients with severe aortic stenosis up to 1-year after the procedure. Additionally, the study will assess the role of geometry in the development of new conduction abnormalities based on the analysis of post-operative CT scan at 1-month in patients who had undergone transcatheter aortic valve replacement with a self-expanding Hydra THV series.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years
  • Patients affected by severe aortic stenosis (NYHA class ≥ II) eligible for TAVI procedure as per local Heart Team evaluation
  • Full understanding and willing to provide informed consent to study enrolment

Exclusion criteria

  • Contraindications to TAVI (e.g., anatomically phenotypes, intracardiac mass, thrombus, vegetation, endocarditis)
  • Refusal to provide informed consent to study enrolment
  • Patients with severe aorta or peripheral artery disease precluding transfemoral approach of TAVI
  • Patients with calcification on the annulus and in the Left Ventricular Outflow Tract (LVOT), or/and excess calcium within each cusp, or those who are deemed unsuitable for the Hydra THV series based on the clinical judgment of the Investigator

Treatment and study plan

Hydra transcatheter aortic valve (THV) series

Device

The Hydra device consists of a self-expanding nitinol frame and three bovine pericardial leaflets in supra-annular position.

Primary outcomes

  1. Primary safety endpoint

    Time frame: 30 days

    Early safety as defined by VARC-3, as composite of:

    • Freedom from all-cause mortality;
    • Freedom from all stroke;
    • Freedom from VARC 3 type 3-4 bleeding;
    • Freedom from major vascular, access-related, or cardiac structural complication;
    • Freedom from acute kidney injury stage 3 or 4;
    • Freedom from moderate or severe aortic regurgitation;
    • Freedom from new permanent pacemaker due to procedure-related conduction abnormalities;
    • Freedom from surgery or intervention related to the device.

  2. Primary performance endpoint

    Time frame: 30 days

    Device success as defined by VARC-3, as composite of:

    • Technical success;
    • Freedom from mortality;
    • Freedom from surgery or intervention related to the device or to a major vascular or access related or cardiac structural complication;
    • Intended performance of the valve (mean gradient <20mmHg, peak velocity <3 m/s, Doppler velocity index ≥0.25, and less than moderate aortic regurgitation).

Secondary outcomes

  1. Technical success

    Time frame: Immediately after procedure

  2. Cardiovascular mortality

    Time frame: 30 days, and 1-year

  3. All-cause mortality

    Time frame: 30 days, and 1-year

  4. All stroke

    Time frame: 30 days, and 1-year

  5. Disabling stroke

    Time frame: 30 days, and 1-year

  6. Myocardial infarction

    Time frame: 30 days, and 1-year

  7. Major vascular complication

    Time frame: 30 days

  8. Acute kidney injury

    Time frame: 30 days

  9. New permanent pacemaker implantation due to procedure related conduction abnormalities

    Time frame: 30 days, and 1-year

  10. New-onset atrial fibrillation

    Time frame: 30 days, and 1-year

  11. Coronary artery obstruction requiring intervention

    Time frame: 30 days, and 1-year

  12. Re-hospitalization for procedure- or valve-related causes

    Time frame: 30 days, and 1-year

  13. Mean aortic valve gradient

    Time frame: 30 days, and 1-year

  14. Effective Orifice Area (EOA)

    Time frame: 30 days, and 1-year

  15. Paravalvular leak

    Time frame: 30 days, and 1-year

  16. New York Heart Association (NYHA) functional class

    Time frame: 30 days, and 1-year

  17. Quality-of-life evaluation

    Time frame: 30 days, and 1-year

  18. Bioprosthetic Valve Failure (BVF)

    Time frame: 30 days, and 1-year

  19. Bioprosthetic valve dysfunction (BVD)

    Time frame: 30 days, and 1-year

  20. Stroke or peripheral embolism

    Time frame: 30 days, and 1-year

  21. VARC-3 Type 3-4 bleeding secondary to or exacerbated by antiplatelet or anticoagulant agents used specifically for valve-related concerns

    Time frame: 30 days, and 1-year

  22. Rates of Hypoattenuated Leaflet Thickening (HALT)

    Time frame: 30 days

  23. Rates of Reduced leaflet motion (RLM)

    Time frame: 30 days

  24. Commissural alignment

    Time frame: 30 days

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Sahajanand Medical Technologies Limited

Industry

Collaborators

  • Qmed Consulting A/S

Registry information

Official study title

Prospective Observational Single-centre Study on the Efficacy and Safety of Hydra Transcatheter Aortic Valve

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2024
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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