Aortic Valve StenosisRADIANT CANADANCT02838680
Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA
A study testing HLT Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by HLT Inc. at 2 sites in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- HLT Transcatheter Aortic Valve System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesCanada
- Study dates
- Dec 2016to 31 Oct 2022
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval
Québec, Quebec, G1V 4G5
Sunnybrook Health Sciences Center
Toronto, Ontario, M4N 3M5
About this study
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.
- Conditions
- Aortic Valve Stenosis
- Being tested
- HLT Transcatheter Aortic Valve System
- Keywords
- aortic stenosis, transcatheter aortic valve replacement (TAVR)
- 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.
HLT Transcatheter Aortic Valve SystemDevice
Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
| Study group | Role | What they receive |
|---|---|---|
| HLT Transcatheter Aortic Valve System | Experimental | Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System Receives: Device: HLT Transcatheter Aortic Valve System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint: Mortality at 30 days
The primary safety endpoint is all-cause mortality at 30 days
Measured: 30 days
Secondary outcomes (5)
Secondary Performance Endpoint 1: Procedural Device Performance
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)
Measured: 1 day
Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Effective Orifice Area)
Aortic valve effective orifice area (EOA) will be evaluated with echocardiograms
Measured: 1 week, 1, 6, 12, 24, 36, 48 and 60 months
Secondary Performance Endpoint 2: Post-procedural Valve Performance (Severity of Aortic Valve Regurgitation)
Severity of aortic valve regurgitation (AR) will be evaluated with echocardiograms
Measured: 1 week, 1, 6, 12, 24, 36, 48 and 60 months
Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Gradient)
Aortic valve gradient will be evaluated with echocardiograms
Measured: 1 week, 1, 6, 12, 24, 36, 48 and 60 months
Secondary Safety Endpoint 3: Adverse Events
All adverse events will be assessed throughout the 5 year follow up period.
Measured: throughout the 5 year follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2016 (estimated)
- Study startDec 2016
- Primary completion9 Apr 2018
- Study completion31 Oct 2022
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- HLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Josep Rodés-Cabau, MD, Principal investigator, Institut universitaire de cardiologie et de pneumologie de Québec, University LavalHarindra Wijeysundera, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02838680
- Sponsor's protocol ID
- HLT1502
- Acronym
- RADIANT CANADA
- Status last verified
- May 2023
- First submitted
- 13 Jul 2016
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Rodes-Cabau J, Williams MR, Wijeysundera HC, Kereiakes DJ, Paradis JM, Staniloae C, Saric M, Radhakrishnan S, Wilson RF, Kubo SH. Transcatheter Aortic Valve Replacement With the HLT Meridian Valve. Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31.
PubMed 31362540
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve Feasibility Trial CANADA
- ClinicalTrials.gov ID
- NCT02838680
- Acronym / sponsor ID
- RADIANT CANADA / HLT1502
- Conditions
- Aortic Valve Stenosis
- Keywords
- aortic stenosis, transcatheter aortic valve replacement (TAVR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- HLT Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2016 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 20 Jul 2016 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLT Transcatheter Aortic Valve System | Experimental | Device: HLT Transcatheter Aortic Valve SystemTranscatheter aortic valve replacement with HLT Transcatheter Aortic Valve System |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (27 listed)
- 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
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 |
|---|---|---|
| HLT Transcatheter Aortic Valve SystemTranscatheter aortic valve replacement with HLT Transcatheter Aortic Valve System | Device | HLT Transcatheter Aortic Valve System |
Primary outcome
Primary Endpoint: Mortality at 30 days
Time frame: 30 days
The primary safety endpoint is all-cause mortality at 30 days
5 secondary outcomes
Secondary Performance Endpoint 1: Procedural Device Performance
Time frame: 1 day
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
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
Secondary Performance Endpoint 2: Post-procedural Valve Performance (Aortic Valve Gradient)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Results publication: PubMed 31362540Rodes-Cabau J, Williams MR, Wijeysundera HC, Kereiakes DJ, Paradis JM, Staniloae C, Saric M, Radhakrishnan S, Wilson RF, Kubo SH. Transcatheter Aortic Valve Replacement With the HLT Meridian Valve. Circ Cardiovasc Interv. 2019 Aug;12(8):e008053. doi: 10.1161/CIRCINTERVENTIONS.119.008053. Epub 2019 Jul 31.
- Individual participant dataSharing planned: No
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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.
Josep Rodés-Cabau, MD principal investigator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Harindra Wijeysundera, MD principal investigator
Sunnybrook Health Sciences Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLT Transcatheter Aortic Valve System in people with Aortic Valve Stenosis, run by HLT Inc. at 2 sites in Canada.
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 27 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: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Endpoint: Mortality at 30 days (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 NCT02838680, 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 31 May 2023.