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Trial record 1 of 1 for:    NCT02838680
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Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA (RADIANT CANADA)

This study is currently recruiting participants.
Verified May 2017 by HLT Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02838680
First Posted: July 20, 2016
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HLT Inc.
  Purpose
To evaluate the safety and performance of the HLT System in patients with severe aortic stenosis who present at high risk for aortic valve replacement surgery.

Condition Intervention
Aortic Valve Stenosis Device: HLT Transcatheter Aortic Valve System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA

Resource links provided by NLM:


Further study details as provided by HLT Inc.:

Primary Outcome Measures:
  • Primary Endpoint: Mortality at 30 days [ Time Frame: 30 days ]
    The primary safety endpoint is all-cause mortality at 30 days


Secondary Outcome Measures:
  • Secondary Performance Endpoint 1: Procedural Device Performance [ Time Frame: 1 day ]

    The secondary performance endpoint is Device Success defined as:

    • Absence of procedural mortality AND
    • Correct positioning of a single Valve into the proper anatomical location AND
    • Intended performance of the Valve (no severe prosthesis-patient mismatch and clinically acceptable gradient) AND no moderate or severe aortic valve regurgitation)

  • Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Effective Orifice Area) [ Time Frame: 1 week, 1, 6, 12, 24, 36, 48 and 60 months ]
    Aortic valve effective orifice area (EOA) will be evaluated with echocardiograms

  • Secondary Performance Endpoint 2: Post-procedural Valve Performance (Severity of Aortic Valve Regurgitation) [ Time Frame: 1 week, 1, 6, 12, 24, 36, 48 and 60 months ]
    Severity of aortic valve regurgitation (AR) will be evaluated with echocardiograms

  • Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Gradient) [ Time Frame: 1 week, 1, 6, 12, 24, 36, 48 and 60 months ]
    Aortic valve gradient will be evaluated with echocardiograms

  • Secondary Safety Endpoint 3: Adverse Events [ Time Frame: throughout the 5 year follow up period ]
    All adverse events will be assessed throughout the 5 year follow up period.


Estimated Enrollment: 20
Study Start Date: December 2016
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
Device: HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   70 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 70 years of age or older
  2. Echocardiographic or hemodynamic based evidence of calcific (senile) aortic stenosis with one of the following: aortic valve EOA <1.0 cm2 or 0.6 cm2/m2 , mean aortic valve gradient >40 mmHg or peak aortic valve velocity >4 m/sec
  3. Symptomatology due to aortic stenosis resulting in one of the following:

    1. NYHA Functional Classification of II or greater
    2. Presence of angina
    3. Presence of syncope
  4. Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter
  5. STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities.
  6. Geographically available, willing to comply with follow up and able to provide written informed consent

Exclusion Criteria:

  1. Congenital unicuspid or bicuspid aortic valve, or noncalcified aortic valve; or valve eccentricity (calcific or otherwise) that in the opinion of the investigator could compromise procedural success.
  2. Patients at high risk for coronary obstruction in the opinion of the investigator (e.g. combination of a coronary height < 12 mm and coronary sinus diameter < 30 mm)
  3. Patients with low flow/low gradient aortic stenosis
  4. Patients with significant annular calcification (e.g. Agatston score > 4000)
  5. Pre-existing prosthetic heart valve in any position, or prosthetic ring
  6. Severe aortic, mitral or tricuspid valve regurgitation
  7. Moderate to severe mitral stenosis
  8. Myocardial infarction within the past 30 days*
  9. Echocardiographic evidence of intracardiac mass, thrombus or vegetation
  10. LVEF < 30%
  11. Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
  12. Hemodynamic instability requiring inotropic drug therapy within the past 14 days
  13. Untreated clinically significant coronary artery disease requiring revascularization
  14. Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
  15. Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
  16. Patient ineligible for or refuses blood transfusions
  17. Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification, severe tortuosity or vessels < 6 mm) that would preclude passage of catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
  18. Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
  19. Symptoms of carotid or vertebral artery disease (e.g. stroke or transient ischemic attack) within past 6 month, or treatment of carotid stenosis within past two months*
  20. Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
  21. Active infection requiring ongoing treatment
  22. Need for emergent surgery or intervention other than the investigational procedure
  23. Any therapeutic invasive cardiac procedure performed or planned to perform within 30 days of the index procedure except for PCI which is within 7 days of the index procedure*
  24. Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
  25. Life expectancy < 1 year due to non-cardiac co-morbid conditions
  26. Currently participating in any investigational drug or device studies that may confound the results of this study
  27. History of any cognitive or mental health status that would interfere with study participation * At the time of procedure, if a subject's medical status has changed since enrollment, the subject shall be re-evaluated for eligibility.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02838680


Contacts
Contact: Jing Li, PhD 763-416-7535 Jing.Li@HLTMedical.com
Contact: Angie Swenson 763-416-7517 Angie.Swenson@HLTMedical.com

Locations
Canada, Ontario
Sunnybrook Health Sciences Center Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Harindra Wijeysunder, MD    416-480-7527    harindra.wijeysundera@sunnybrook.ca   
Contact: Camalene Chrysotoum, HBSc, CCRA    416-480-6100 ext 89724    camalene.chrysostoum@sunnybrook.ca   
Canada, Quebec
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval Recruiting
Québec City, Quebec, Canada, G1V 4G5
Contact: Josep Rodés-Cabau, MD    418-656-8711    josep.rodes@criucpq.ulaval.ca   
Contact: Claire Gibrat, Ph. D    418-656-8711 ext 3473    claire.gibrat@criucpq.ulaval.ca   
Sponsors and Collaborators
HLT Inc.
Investigators
Study Chair: Josep Rodés-Cabau, MD Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Principal Investigator: Harindra Wijeysundera, MD Sunnybrook Health Sciences Center
  More Information

Responsible Party: HLT Inc.
ClinicalTrials.gov Identifier: NCT02838680     History of Changes
Other Study ID Numbers: HLT1502
First Submitted: July 13, 2016
First Posted: July 20, 2016
Last Update Posted: May 30, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by HLT Inc.:
aortic stenosis
transcatheter aortic valve replacement (TAVR)

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction