A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

The purpose of this study is the evaluation of the performance, safety and efficacy of Hydra Aortic valve in real-world patients. Following initial implantation, all patients will have clinical follow up at 30 days, 3, months, 6 months and 12 months

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Valve Stenosis
• Intervention / Treatment: Device: Hydra TAVI

Detailed Description

This study is a multicenter, prospective, non-randomized investigational study designed to assess the safety and performance of the HYDRA Aortic valve and delivery system. Primary endpoint for safety is the 30 day all cause mortality rate. Primary endpoint for performance is the acute device success. In addition, the efficacy of the HYDRA Aortic valve and delivery system will be evaluated. Up to 165 patients will be enrolled in the study in order to achieve 150 subjects successfully implanted.

All patients will have a clinical follow-up at 30 days, 3months, 6 months and 12 months post implant. The follow-up procedure table is shown in Appendix A.

The patient is enrolled in the study as a subject only upon signature of the informed consent. All subjects will be reviewed by the Principal Investigator prior to undergoing the implant procedure for the Hydra Aortic Heart Valve.

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece
    • General Hospital of Athens Ippokration
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital
• Lithuania
  • Vilnius, Lithuania
    • Vilnius University Hospital Santariskiu Klinikos
• New Zealand
  • Hamilton, New Zealand
    • Waikato Hospital
• Poland
  • Warsaw, Poland, 04-628
    • Instytut Kardiologii im.Prymasa
• Thailand
  • Bangkok, Thailand, 10330
    • King Chulalongkorn Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subject has given written Informed Consent for study participation prior to procedure.
2. Greater than 55 years of age.
3. Aortic annulus diameter meets the range 18 to 27mm as measured by CT conducted within the past 180 days, or echocardiogram (TEE 3D recommended) if medically contraindicated to CT.
4. Patient has severe degenerative aortic stenosis with echocardiography derived mean gradient >40mmHg and/or peak velocity greater than 4.0 m/s and/or an initial valve area of <1.0 cm2.
5. Patient has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
6. Patient is deemed high operable risk and suitable for TAVI.
7. Patient's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
8. Patient has structurally normal cardiac anatomy.
9. Willing and able to comply with all required follow-up evaluation

Exclusion Criteria:

1. Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
2. Patient has carotid artery disease requiring intervention.
3. Patient has evidence of a myocardial infarction (MI) within the past 6 months.
4. Patient has hypertrophic cardiomyopathy.
5. Patient has a native aortic valve that is congenitally uni-cuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
6. Patient has mitral or tricuspid valvular regurgitation (≥ grade III) or moderate to severe mitral stenosis.
7. Patient has aortic root angulation >70 degrees (horizontal aorta).
8. Patient has aortic root diameter of < 26 mm or >36 mm.
9. Patient has a pre-existing prosthetic valve or prosthetic ring in any position.
10. Patient refuses blood transfusion or surgical valve replacement.
11. Patient has resting left ventricular ejection fraction (LVEF) < 20%.
12. Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
13. Patient has severe basal septal hypertrophy.
14. Patient has had a percutaneous interventional or other invasive cardiac or peripheral procedure ≤ 14 days of the index procedure (does not apply for diagnostic angiography or Angio-CT).
15. Patient has a history of or has active endocarditis.
16. Patient has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
17. Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
18. Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
19. Patient with significant pulmonary disease (FEV1 < 30% as predicted).
20. Patient has significant chronic steroid use as determined and documented by the Principal Investigator.
21. Patient has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
22. Patient has renal insufficiency as evidenced by a serum creatinine > 3.0 mg/dL (265.5μmol/L) or end-stage renal disease requiring chronic dialysis.
23. Patient's iliofemoral arteries have severe calcification, tortuosity (>two 90 degree bends), diameter <6mm, or subject has had an aorto-femoral bypass that preclude safe placement of a 18 French sheath.
24. Patient has blood dyscrasia (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy).
25. Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
26. Patient has significant aortic disease.
27. Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the iliofemoral arteries.
28. Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure
29. Patient has a life expectancy < 12 months.
30. Patient has other medical, social or psychological conditions that, in the opinion of the Principal Investigator, preclude the subject from study participation.
31. Patient has a known allergy to contrast media, nitinol alloys or bovine tissue.
32. Patient has a history of any cognitive or mental health status that would interfere with study participation.
33. Currently participating in another trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydra TAVI; Percutaneous Replacement of the Diseased Aortic Valve	Device: Hydra TAVI; Percutaneous Replacement of the Diseased Aortic Valve; Other Names: TAVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	30-day mortality of procedure is defined as all deaths occurred in subjects attending the Hydra prosthesis implantation within 30 days post procedure. All deaths include in-hospital mortality, cardiac death, valve-related death, and death of unknown cause	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	Composite outcome measures consisting of Effective orifice area, mean aortic valve gradient, degree of prosthetic valve regurgitation.	3, 6, and 12 months

Collaborators and Investigators

• Sponsor: Vascular Innovations Co. Ltd.
• Collaborators: MedPass International

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2015
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): July 1, 2025

Study Registration Dates

• First Submitted: April 27, 2015
• First Submitted That Met QC Criteria: April 29, 2015
• First Posted (Estimate): May 5, 2015

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: VI-CL-HYDRA-02

Drug and device information, study documents

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