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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02434263




Registration number
NCT02434263
Ethics application status
Date submitted
27/04/2015
Date registered
5/05/2015
Date last updated
5/02/2020

Titles & IDs
Public title
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
Scientific title
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
Secondary ID [1] 0 0
VI-CL-HYDRA-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Aortic Valve Stenosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Hydra TAVI

Experimental: Hydra TAVI - Percutaneous Replacement of the Diseased Aortic Valve


Treatment: Devices: Hydra TAVI
Percutaneous Replacement of the Diseased Aortic Valve

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
30 days
Secondary outcome [1] 0 0
Procedural Success - Composite outcome measures consisting of Effective orifice area, mean aortic valve gradient, degree of prosthetic valve regurgitation.
Timepoint [1] 0 0
3, 6, and 12 months

Eligibility
Key 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
Minimum age
55 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Greece
State/province [1] 0 0
Athens
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Hong Kong
Country [3] 0 0
Lithuania
State/province [3] 0 0
Vilnius
Country [4] 0 0
New Zealand
State/province [4] 0 0
Hamilton
Country [5] 0 0
Poland
State/province [5] 0 0
Warsaw
Country [6] 0 0
Thailand
State/province [6] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vascular Innovations Co. Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
MedPass International
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT02434263
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marie Jose Sousa
Address 0 0
Country 0 0
Phone 0 0
+33142128861
Fax 0 0
Email 0 0
mariejosesousa@medpass.org
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02434263