A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve

NCT02434263 | Unknown DMC

• 1 other identifier: VI-CL-HYDRA-02
• Study Type: interventional
• Target: 165
• Locations: 6 countries
• Sites: 6

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

Conditions

Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Procedural Success

  3, 6, and 12 months

Study Arms (1)

Hydra TAVI

EXPERIMENTAL

Percutaneous Replacement of the Diseased Aortic Valve

Device: Hydra TAVI

Interventions

Hydra TAVI DEVICE

Percutaneous Replacement of the Diseased Aortic Valve

Also known as: TAVR

Hydra TAVI

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Vascular Innovations Co. Ltd.: lead
• MedPass International: collaborator

Study Sites (6)

General Hospital of Athens Ippokration

Athens, Greece

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Vilnius University Hospital Santariškiu Klinikos

Vilnius, Lithuania

Location

Waikato Hospital

Hamilton, New Zealand

Location

Instytut Kardiologii im.Prymasa

Warsaw, 04-628, Poland

Location

King Chulalongkorn Hospital

Bangkok, 10330, Thailand

Location

Related Publications (1)

• 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.

  PMID: 34991828 DERIVED

MeSH Terms

Conditions

Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2015
• First Posted: May 5, 2015
• Study Start: August 13, 2015
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2025
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

TH (1); LI (1); GR (1); NZ (1); HK (1); PL (1)