Aortic Valve StenosisNCT02434263
A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
A study testing Hydra TAVI in people with Aortic Valve Stenosis, run by Vascular Innovations Co. Ltd. at 6 sites in 6 countries.
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 Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- Hydra TAVI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 13 Aug 2015to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has given written Informed Consent for study participation prior to procedure.
- Greater than 55 years of age.
- 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.
- 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.
- Patient has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
- Patient is deemed high operable risk and suitable for TAVI.
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- Patient's predicted operative mortality or serious, irreversible morbidity risk is <50% at 30 days.
- Patient has structurally normal cardiac anatomy.
- Willing and able to comply with all required follow-up evaluation
Who cannot join
- Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
- Patient has carotid artery disease requiring intervention.
- Patient has evidence of a myocardial infarction (MI) within the past 6 months.
- Patient has hypertrophic cardiomyopathy.
- Patient has a native aortic valve that is congenitally uni-cuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
- Patient has mitral or tricuspid valvular regurgitation (≥ grade III) or moderate to severe mitral stenosis.
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- Patient has aortic root angulation >70 degrees (horizontal aorta).
- Patient has aortic root diameter of < 26 mm or >36 mm.
- Patient has a pre-existing prosthetic valve or prosthetic ring in any position.
- Patient refuses blood transfusion or surgical valve replacement.
- Patient has resting left ventricular ejection fraction (LVEF) < 20%.
- Patient has documented, untreated symptomatic coronary artery disease (CAD) requiring revascularization.
- Patient has severe basal septal hypertrophy.
- 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).
- Patient has a history of or has active endocarditis.
- Patient has echocardiographic evidence of intracardiac mass, thrombus, or vegetation.
- Patient has hemodynamic instability (requiring inotropic support or mechanical heart assistance).
- Patient is in acute pulmonary edema or requiring intravenous diuretic therapy to stabilize heart failure.
- Patient with significant pulmonary disease (FEV1 < 30% as predicted).
- Patient has significant chronic steroid use as determined and documented by the Principal Investigator.
- Patient has a known hypersensitivity or contraindication to anticoagulant or antiplatelet medication.
- 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.
- 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.
- Patient has blood dyscrasia (leukopenia, acute anemia, thrombocytopenia, bleeding diathesis, or coagulopathy).
- Patient has a current autoimmune disease that, in the opinion of the Principal Investigator precludes the subject from study participation.
- Patient has significant aortic disease.
- Patient has a pre-existing endovascular stent graft in the supra- or infrarenal aorta or pre-existing stent grafts in the iliofemoral arteries.
- Patient has an active peptic ulcer or has had gastrointestinal (GI) bleeding within the past 90 days prior to procedure
- Patient has a life expectancy < 12 months.
- Patient has other medical, social or psychological conditions that, in the opinion of the Principal Investigator, preclude the subject from study participation.
- Patient has a known allergy to contrast media, nitinol alloys or bovine tissue.
- Patient has a history of any cognitive or mental health status that would interfere with study participation.
- Currently participating in another trial.
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
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
Read the 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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- Hydra TAVI
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydra TAVIDevice
Also called TAVR
Percutaneous Replacement of the Diseased Aortic Valve
| Study group | Role | What they receive |
|---|---|---|
| Hydra TAVI | Experimental | Percutaneous Replacement of the Diseased Aortic Valve Receives: Device: Hydra TAVI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days
Secondary outcomes (1)
Procedural Success
Composite outcome measures consisting of Effective orifice area, mean aortic valve gradient, degree of prosthetic valve regurgitation.
Measured: 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study start13 Aug 2015
- Primary completionJul 2022 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vascular Innovations Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434263
- Sponsor's protocol ID
- VI-CL-HYDRA-02
- Status last verified
- Oct 2021
- First submitted
- 27 Apr 2015
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34991828
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve
- ClinicalTrials.gov ID
- NCT02434263
- Acronym / sponsor ID
- VI-CL-HYDRA-02
- Conditions
- Aortic Valve Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Vascular Innovations Co. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- MedPass International
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydra TAVI | Experimental | Device: Hydra TAVIPercutaneous Replacement of the Diseased Aortic Valve |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject has given written Informed Consent for study participation prior to procedure.
- Greater than 55 years of age.
- 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.
- 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.
- Patient has symptomatic aortic stenosis as demonstrated by NYHA Functional Classification of II or greater.
Key exclusion criteria (33 listed)
- Patient has a history of a cerebral vascular accident (CVA) or transient ischemic attack (TIA) within the past 6 months.
- Patient has carotid artery disease requiring intervention.
- Patient has evidence of a myocardial infarction (MI) within the past 6 months.
- Patient has hypertrophic cardiomyopathy.
- Patient has a native aortic valve that is congenitally uni-cuspid, bicuspid, quadricuspid or non-calcified as seen by echocardiography.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydra TAVIAlso: TAVRPercutaneous Replacement of the Diseased Aortic Valve | Device | Hydra TAVI |
Primary outcome
All cause mortality
Time frame: 30 days
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
1 secondary outcome
Procedural Success
Time frame: 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Derived from this study: PubMed 34991828Aidietis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydra TAVI in people with Aortic Valve Stenosis, run by Vascular Innovations Co. Ltd. at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece, Hong Kong, Lithuania, New Zealand, Poland and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02434263, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.