Mitral RegurgitationHighFLONCT04888247
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
A study testing CLARITY in people with Mitral Regurgitation, run by HighLife SAS at 14 sites in 6 countries.
Trial summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- CLARITY
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 1 Jul 2021to 1 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Moderate-severe or severe mitral regurgitation (≥ 3+)
- Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
- Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability
- Patient meets the anatomical criteria for HighLife valve
- Patient is willing to participate in the study and provides signed informed consent
- Patients with a high risk for LVOTO
Who cannot join
- Any stroke/TIA within 30 days
- Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
- Active infections requiring antibiotic therapy
- Active ulcer or gastro-intestinal bleeding in the past 3 months
- History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
- Patients in whom TEE is not feasible
Show all 14Show fewer
- Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
- Patient is unable to comply with the follow-up schedule and assessments
- Participation in another clinical investigation at the time of inclusion
- Patient has known allergies to the device components or contrast medium
- Patient cannot tolerate anticoagulation or antiplatelet therapy
- Patients with a life expectancy of less than 12 months due to non-cardiac conditions
- Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months
- -
Trial locations and contacts
14 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 6 countries
France4 sites, 4 recruiting
- Recruiting
CHU Lille
Lille, 59000
Eric Van Belle, MD, eric.vanbelle@chu-lille.fr
- Recruiting
Centre Hospitalo - Univ de Nantes
Nantes, 44000
Vincent Letocart, MD, vincent.letocart@chu-nantes.fr
- Recruiting
CHU de Rennes
Rennes
Guillaume Leurent, MD
Guillaume Leurent, MD
- Recruiting
Cliniue Pasteur
Toulouse, 31076
Didier Tchetche, +33562211699, dtchetche@clinique-pasteur.com
Australia3 sites, 2 recruiting
- Recruiting
Wesley Hospital
Auchenflower
Anthony Camuglia, MD
Anthony Camuglia, MD
- Recruiting
Mount Hospital
Perth
Wen Yeow, MD, +61 8 9400 6217, wyeow@heartwest.com.au
Wen Yeow, MD
- Terminated
Macquarie University Hospital
Sydney
Belgium2 sites, 2 recruiting
- Recruiting
AZ St. Jan - Brugge
Bruges
Jan van der Heyden, MD
Jan van der Heyden, MD
- Recruiting
UZ Leuven
Leuven
Christophe Dubois, MD
Christophe Dubois, MD
Germany2 sites, 2 recruiting
- Recruiting
Deutsches Herzzentrum Munchen
Munich
Michael Joner, MD
Michael Joner, MD
- Recruiting
University Hospital Ulm
Ulm
Wolfgang Rottbauer, MD
Wolfgang Rottbauer, MD
Poland2 sites, 2 recruiting
- Recruiting
Medical University of Silesia
Katowice
Wojciech Wojakowski, MD
Wojciech Wojakowski, MD
- Recruiting
Medical University of Warsaw
Warsaw
Zenon Huczek, MD
Zenon Huczek, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Brighton and Sussex University Hospital
Brighton
David Hildick-Smith, MD
David Hildick-Smith, MD
About this study
Official title: HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Read the detailed description
Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).
- Conditions
- Mitral Regurgitation
- Being tested
- CLARITY
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLARITYDevice
Trans-septal mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Trans-septal mitral valve replacement Receives: Device: CLARITY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of subjects meeting Technical Success
- Successful vascular access, delivery and retrieval of the HighLife delivery systems
- Deployment and correct positioning of the HighLife 28mm CLARITY TSMV
- Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE
- Successful vascular access, delivery and retrieval of the HighLife delivery systems
- Deployment and correct positioning of the HighLife 28mm CLARITY TSMV
- Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Jul 2021
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HighLife SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888247
- Sponsor's protocol ID
- HL-2021-01
- Acronym
- HighFLO
- Status last verified
- Oct 2024
- First submitted
- 4 May 2021
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HighLife TSMVR Feasibility Study of the Open Cell CLARITY Valve in Patients With Moderate-severe or Severe MR, High Surgical Risk and With a High Risk for Left Ventricular Outflow Tract Obstruction (LVOTO)
- ClinicalTrials.gov ID
- NCT04888247
- Acronym / sponsor ID
- HighFLO / HL-2021-01
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- HighLife SASIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Feb 2031 (estimated)
- First posted
- 17 May 2021 (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.
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Detailed description
Study to assess the feasibility, safety, and performance of the HighLife CLARITY TSMV, and its deliver systems, in NYHA Class ≥ II-IV patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment according to the local multidisciplinary Heart Team decision, and who are at high risk for potential LVOT obstruction(LVOTO).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: CLARITYTrans-septal mitral valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Moderate-severe or severe mitral regurgitation (≥ 3+)
- Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
- Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
- Patient is high-risk for open-heart surgery based on the assessment of the multidisciplinary Heart Team using standard scoring systems and consideration of co-morbidities, frailty, and disability
Key exclusion criteria (14 listed)
- Any stroke/TIA within 30 days
- Severe symptomatic carotid stenosis (> 70% by non-invasive imaging)
- Active infections requiring antibiotic therapy
- Active ulcer or gastro-intestinal bleeding in the past 3 months
- History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
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 |
|---|---|---|
| CLARITYTrans-septal mitral valve replacement | Device | Treatment |
Primary outcome
Rate of subjects meeting Technical Success
Time frame: 24 hours
* Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE * Successful vascular access, delivery and retrieval of the HighLife delivery systems * Deployment and correct positioning of the HighLife 28mm CLARITY TSMV * Freedom from additional emergency surgery or re-intervention related to the device or access procedure, that occurred (was initiated) during the procedure. Any emergency surgery or re-intervention that occurs after the patient exits the procedure room/cath lab in stable condition will be captured as an AE/SAE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2024.
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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.
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLARITY in people with Mitral Regurgitation, run by HighLife SAS at 14 sites in 6 countries.
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 8 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Australia, Belgium, Germany, Poland and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luc Verhees (+31 6 4270 2457, lverhees@highlifemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of subjects meeting Technical Success (time frame: 24 hours). 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 3 Oct 2024.