A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

Aortic Valve Stenosis Clinical Trial

Official title:

A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02434263
• Other study ID #: VI-CL-HYDRA-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 13, 2015
• Est. completion date: July 2025

Study information

• Verified date: October 2021
• Source: Vascular Innovations Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: July 2025
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Intervention

Device:
• Hydra TAVI
Percutaneous Replacement of the Diseased Aortic Valve

Locations

Country	Name	City	State
Greece	General Hospital of Athens Ippokration	Athens
Hong Kong	Prince of Wales Hospital	Hong Kong
Lithuania	Vilnius University Hospital Santariškiu Klinikos	Vilnius
New Zealand	Waikato Hospital	Hamilton
Poland	Instytut Kardiologii im.Prymasa	Warsaw
Thailand	King Chulalongkorn Hospital	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Vascular Innovations Co. Ltd.	MedPass International

Countries where clinical trial is conducted

Greece,  Hong Kong,  Lithuania,  New Zealand,  Poland,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Procedural Success	Composite outcome measures consisting of Effective orifice area, mean aortic valve gradient, degree of prosthetic valve regurgitation.	3, 6, and 12 months