- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02838680
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA (RADIANT CANADA)
May 29, 2023 updated by: HLT Inc.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N 3M5
- Sunnybrook Health Sciences Center
-
-
Quebec
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Québec City, Quebec, Canada, G1V 4G5
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec - Université Laval
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
70 years and older (Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 70 years of age or older
- 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
Symptomatology due to aortic stenosis resulting in one of the following:
- NYHA Functional Classification of II or greater
- Presence of angina
- Presence of syncope
- Aortic valve annular diameter ≥ 24 and ≤26 mm measured by MSCT based on area or perimeter
- STS score of ≥8, or documented heart team agreement of high risk for surgical aortic valve replacement (SAVR) due to frailty or comorbidities.
- Geographically available, willing to comply with follow up and able to provide written informed consent
Exclusion Criteria:
- 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.
- 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)
- Patients with low flow/low gradient aortic stenosis
- Patients with significant annular calcification (e.g. Agatston score > 4000)
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
- Severe aortic, mitral or tricuspid valve regurgitation
- Moderate to severe mitral stenosis
- Myocardial infarction within the past 30 days*
- Echocardiographic evidence of intracardiac mass, thrombus or vegetation
- LVEF < 30%
- Severe pulmonary hypertension with pulmonary systolic pressure greater than two-thirds of systemic pressure
- Hemodynamic instability requiring inotropic drug therapy within the past 14 days
- Untreated clinically significant coronary artery disease requiring revascularization
- Presence of significant aortic disease such as atheroma, thrombus, or aneurysm which, in the opinion of the investigator, precludes safe implant delivery
- Blood dyscrasias defined as: acute leukopenia, acute anemia, acute thrombocytopenia, history of bleeding diathesis or coagulopathy
- Patient ineligible for or refuses blood transfusions
- 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
- Active peptic ulcer or gastrointestinal bleeding within the past 90 days*
- 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*
- Renal insufficiency as demonstrated by a serum creatinine > 2.5 mg/dL or end stage renal disease requiring chronic dialysis
- Active infection requiring ongoing treatment
- Need for emergent surgery or intervention other than the investigational procedure
- 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*
- Hypersensitivity or contraindication to procedural medication and device materials (e.g. titanium, nickel, pork) which cannot be adequately pre-medicated
- Life expectancy < 1 year due to non-cardiac co-morbid conditions
- Currently participating in any investigational drug or device studies that may confound the results of this study
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HLT Transcatheter Aortic Valve System
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
|
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary Endpoint: Mortality at 30 days
Time Frame: 30 days
|
The primary safety endpoint is all-cause mortality at 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary Performance Endpoint 1: Procedural Device Performance
Time Frame: 1 day
|
The secondary performance endpoint is Device Success defined as:
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1 day
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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
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Aortic valve effective orifice area (EOA) will be evaluated with echocardiograms
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1 week, 1, 6, 12, 24, 36, 48 and 60 months
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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
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Severity of aortic valve regurgitation (AR) will be evaluated with echocardiograms
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1 week, 1, 6, 12, 24, 36, 48 and 60 months
|
Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Gradient)
Time Frame: 1 week, 1, 6, 12, 24, 36, 48 and 60 months
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Aortic valve gradient will be evaluated with echocardiograms
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1 week, 1, 6, 12, 24, 36, 48 and 60 months
|
Secondary Safety Endpoint 3: Adverse Events
Time Frame: throughout the 5 year follow up period
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All adverse events will be assessed throughout the 5 year follow up period.
|
throughout the 5 year follow up period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harindra Wijeysundera, MD, Sunnybrook Health Sciences Center
- Principal Investigator: Josep Rodés-Cabau, MD, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
April 9, 2018
Study Completion (Actual)
October 31, 2022
Study Registration Dates
First Submitted
July 13, 2016
First Submitted That Met QC Criteria
July 15, 2016
First Posted (Estimated)
July 20, 2016
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 29, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLT1502
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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