- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02159794
HLT transfemOral Replacement of aortIc Valve Via transcatherteriZatiON CANADA (HORIZON CANADA)
March 24, 2015 updated by: HLT Inc.
The purpose of this study is 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
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
Prospective, non-randomized, single arm, single-center first-in-man feasibility trial.
Study Type
Interventional
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
-
-
Quebec
-
Quebec City, Quebec, Canada, G1V 4G5
- Quebec Heart and Lung Institute
-
-
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
75 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 75 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 a New York Heart Association (NYHA) Functional Classification of II or greater
- Aortic valve annular diameter ≥ 21 and ≤23mm measured by MSCT
- An STS score ≥10; or Logistic EuroScore I ≥ 15; or a determination by one cardiovascular surgeon and one cardiologist that the co-morbidities not captured by the STS or EuroScore expected to increase the operative mortality risk to > 15%.
- 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.
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
- Severe (Grade 3 to 4) 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%
- Uncontrolled hypertension (i.e. blood pressure at baseline > 140 mmHg systolic ; or in the opinion of the investigator cannot be controlled by medical therapy).
- 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 or mechanical support within the past 6 months*
- 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 small vessels) 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*
- Stroke or transient ischemic attack within past 6 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, (or 6 months for drug eluting coronary stent or biventricular pacemaker implantation)*
- 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 an HLT Transcatheter Aortic Valve System
|
Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Procedural Device Performance
Time Frame: Post procedure (day of procedure)
|
The primary performance endpoint is the Device Success defined as:
|
Post procedure (day of procedure)
|
Mortality
Time Frame: 30 days
|
The primary safety objective is all-cause mortality at 30 days.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-procedural Valve Performance
Time Frame: post procedure (day of procedure), pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months
|
The HLT Valve performance will be evaluated by the following parameters with echocardiograms obtained at baseline, procedural, pre-discharge, 1, 6, 12, 24, 36, 48 and 60 months:
|
post procedure (day of procedure), pre-discharge (up to 14 days), 1, 6, 12, 24, 36, 48 and 60 months
|
Adverse Events
Time Frame: 5 years
|
All adverse events will be assessed throughout the 5 year follow up period.
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Josep Rodés-Cabau, M.D., Quebec Heart and Lung Institute
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
August 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
March 1, 2020
Study Registration Dates
First Submitted
June 4, 2014
First Submitted That Met QC Criteria
June 6, 2014
First Posted (Estimate)
June 10, 2014
Study Record Updates
Last Update Posted (Estimate)
March 26, 2015
Last Update Submitted That Met QC Criteria
March 24, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HLT1401
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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