Brief Title
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
Official Title
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
Brief 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
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
Primary Outcome
All cause mortality
Secondary Outcome
Procedural Success
Condition
Aortic Valve Stenosis
Intervention
Hydra TAVI
Study Arms / Comparison Groups
Hydra TAVI
Description: Percutaneous Replacement of the Diseased Aortic Valve
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
165
Start Date
August 13, 2015
Completion Date
July 2025
Primary Completion Date
July 2022
Eligibility Criteria
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.
Gender
All
Ages
55 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Greece
Location Countries
Greece
Administrative Informations
NCT ID
NCT02434263
Organization ID
VI-CL-HYDRA-02
Responsible Party
Sponsor
Study Sponsor
Vascular Innovations Co. Ltd.
Collaborators
MedPass International
Study Sponsor
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Verification Date
October 2021