Aortic Valve StenosisRADIANT CENCT03805711
HLT Meridian Valve CE Mark Trial
A study testing HLT® Transcatheter System in people with Aortic Valve Stenosis, run by HLT Inc. at 1 site in Canada.
Trial summary
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortic Valve Stenosis
- What is being tested?
- HLT® Transcatheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- 12 Jul 2019to 20 Sep 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following:
- Aortic valve area ≤ 1.0 cm^2 or 0.6 cm^2/m^2
- Mean aortic valve gradient ≥ 40 mmHg
- Peak aortic valve velocity ≥ 4 m/sec
- Symptoms due to severe aortic stenosis resulting in one of the following:
- NYHA Functional Classification of II or greater
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- Presence of angina
- Presence of syncope
- Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging.
- Patient is considered intermediate or high risk to undergo surgical aortic valve replacement with one of the following:
- Intermediate Surgical Risk: STS-PROM score of ≥ 3% to 8%
- High Surgical Risk: STS-PROM score of ≥ 8%
- Documented heart team agreement of risk for surgical aortic valve replacement (SAVR) due to other factors not captured by risk-scores (i.e. frailty or comorbidities)
- Geographically available, willing to comply with follow up and able to provide written informed consent
Who cannot join
- Patients with a coronary height of <10mm, or otherwise determined to be at high risk for coronary obstruction
- Patients with low flow/low gradient aortic stenosis
- Patients with significant annular or LVOT calcification that could compromise procedural success
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
- Severe aortic, mitral or tricuspid valve regurgitation
- Untreated clinically significant coronary artery disease requiring revascularization
- Unfavorable peripheral vascular anatomy or disease (e.g. severe obstructive calcification or severe tortuosity) that would preclude passage of 18 Fr catheters from the femoral arterial access to the aorta as evidenced by peripheral MSCT
- Need for emergent surgery or intervention other than the investigational procedure
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, G1V 4G5
About this study
Official title: Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial
To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.
Read the detailed description
Prospective, non-randomized, single arm, multi-center CE Mark trial.
- Conditions
- Aortic Valve Stenosis
- Being tested
- HLT® Transcatheter System
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVR, TAVI, Aortic Valve
- 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 SystemDevice
Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).
| Study group | Role | What they receive |
|---|---|---|
| Aortic Valve Replacement with HLT® Transcatheter System | Experimental | Replacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System Receives: Device: HLT® Transcatheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Freedom from all-cause mortality
Measured: 30 days
Secondary outcomes (3)
Procedural Device Performance
Device implant success defined as:
Absence of procedural mortality AND, Correct positioning of a single prosthetic heart valve into the proper anatomical location AND, Intended performance of the prosthetic heart valve (no prosthesis-patient mismatch and mean aortic valve gradient <20mmHg or peak aortic valve velocity <3 m/sec, AND no moderate or severe AR)
Measured: During the Procedure
Post-procedural Valve Performance
Valve performance will be evaluated by an independent Echo Core Laboratory for the following hemodynamic parameters:
- Aortic valve area (AVA)
- Aortic valve regurgitation (AR)
- Aortic valve gradient (Mean and Peak)
Measured: 14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Rate of Adverse Events
- All adverse events through the one (1) year follow up period
- All Serious Adverse Events through the five (5) year follow up period
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) at 30 Days, 6 months, 12 months and annually through five (5) years
Measured: Throughout the 5-year follow-up period, assessed annually at a minimum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start12 Jul 2019
- Primary completion20 Sep 2019
- Study completion20 Sep 2019
Why it stopped: Sponsor decision to stop enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- HLT Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Linke, MD, Principal investigator, Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805711
- Sponsor's protocol ID
- HLT 1801
- Acronym
- RADIANT CE
- Status last verified
- May 2020
- First submitted
- 9 Jan 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfemoral Replacement of Aortic Valve With HLT MeriDIAN Valve CE Mark Trial
- ClinicalTrials.gov ID
- NCT03805711
- Acronym / sponsor ID
- RADIANT CE / HLT 1801
- Conditions
- Aortic Valve Stenosis
- Keywords
- Aortic Stenosis, Transcatheter Aortic Valve Replacement, TAVR, TAVI, Aortic Valve
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor decision to stop enrollment.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- HLT Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2019 (actual)
- Primary completion
- 20 Sep 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 16 Jan 2019 (actual)
- 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 symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery.
Detailed description
Prospective, non-randomized, single arm, multi-center CE Mark trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aortic Valve Replacement with HLT® Transcatheter System | Experimental | Device: HLT® Transcatheter SystemReplacement of aortic valve using the HLT® Transcatheter System (HLT System) comprised of The Meridian® II Valve with TriVent™ Anticalcification Treatment and The Pathfinder® II Delivery System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- Echocardiographic or hemodynamic based evidence of severe aortic stenosis with one of the following:
- Symptoms due to severe aortic stenosis resulting in one of the following:
- Documented aortic valve annular size of ≥ 24 and ≤ 26 mm (associated perimeter range is 76-81mm or associated area range of 453-530 mm2) by the MSCT Core Lab assessment of pre-procedure imaging.
- Patient is considered intermediate or high risk to undergo surgical aortic valve replacement with one of the following:
- Geographically available, willing to comply with follow up and able to provide written informed consent
Key exclusion criteria (8 listed)
- Patients with a coronary height of <10mm, or otherwise determined to be at high risk for coronary obstruction
- Patients with low flow/low gradient aortic stenosis
- Patients with significant annular or LVOT calcification that could compromise procedural success
- Pre-existing prosthetic heart valve in any position, or prosthetic ring
- Severe aortic, mitral or tricuspid valve regurgitation
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 SystemTranscatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%). | Device | Aortic Valve Replacement with HLT® Transcatheter System |
Primary outcome
All-cause mortality
Time frame: 30 days
Freedom from all-cause mortality
3 secondary outcomes
Procedural Device Performance
Time frame: During the Procedure
Post-procedural Valve Performance
Time frame: 14 Days (or earlier if discharged prior to post-op Day 14), 30 Days, 6 months, 12 months, 24 months, 36 months, 48 months and 60 months
Rate of Adverse Events
Time frame: Throughout the 5-year follow-up period, assessed annually at a minimum
Results and safety
The study was stopped early (reason given: Sponsor decision to stop enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- 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.
Axel Linke, MD principal investigator
Klinik für Innere Medizin und Kardiologie, Herzzentrum Dresden Universitätsklinik
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HLT® Transcatheter System in people with Aortic Valve Stenosis, run by HLT Inc. at 1 site 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 14 inclusion and 8 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: stopped early, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Sponsor decision to stop enrollment.). Results are not available in the source record.
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?
All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2020; AzTrials last refreshed its copy on 27 Oct 2026.