Mitral Valve (MV) RegurgitationHIGHFIVENCT06683729
HighLife Clarity Treatment of Severe Mitral Regurgitation
A study testing Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system in people with Mitral Valve (MV) Regurgitation, run by HighLife SAS.
Trial summary
The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve (MV) Regurgitation
- What is being tested?
- Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2025to Jun 2034
- 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
- Based on local regulations, the subject meets the legal minimum age to provide informed consent
- Moderate-to-severe or severe symptomatic MR (≥3+) by transthoracic echocardiography (TTE) which is primarily due to lack of mitral leaflet coaptation, secondary to either a) LV cardiomyopathy with restriction of the mitral leaflet(s), or b) mitral annular dilatation due to chronic atrial fibrillation or other cause, as confirmed by the echocardiographic core laboratory (note: some element of primary (degenerative) MR may be present, but the core lab must agree that the principal etiology is secondary MR)
- New York Heart Association (NYHA) functional class II, III or ambulatory IV
- Based on the assessment of the local multidisciplinary heart team, the patient is:
- being treated with stable maximally-tolerated doses of guidelines class I indicated GDMT for at least one month, and CRT for at least 3 months (if applicable)
- not indicated for heart surgery (mitral valve repair or replacement) according to guidelines and the local standard of care
- unsuitable for treatment with transcatheter edge-to-edge repair (complex TEER anatomy) as assessed by the site interventional cardiologist(s)
Who cannot join
- Any stroke or TIA within 30 days prior to procedure; any prior intracranial hemorrhage at any time; or any intracerebral mass, arteriovenous fistula or other malformation or defect predisposing to bleeding
- Known severe carotid stenosis (>70% diameter stenosis by non-invasive imaging) or carotid stenting or carotid endarterectomy within 30 days)
- History of bleeding diathesis, coagulopathy, clotting disorder, or refusal of future blood transfusion or bleeding in the 3 months prior to procedure other than minor cutaneous bleeding
- Patients in whom transesophageal echo (TEE) is not feasible
- Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
- Female subjects of childbearing potential who are not willing or able to comply with the use of contraception, or who are pregnant or lactating, or plan to get pregnant within the next 12 months.
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- Participation in another clinical study of an investigational drug or device at the time of inclusion that has not reached its primary endpoint
- Patient has known allergies to the device components or contrast medium, which cannot be medically managed
- Patient cannot tolerate anticoagulation (i.e. warfarin), or not willing to take anticoagulation for at least 6 months, or antiplatelet agents (i.e. aspirin, clopidogrel)
- Patient with a life expectancy of less than 12 months, or otherwise is unable to comply with the follow-up schedule and assessments
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Prof Stephen Brecker, MD Chief Medical Office, HighLife contact
About this study
The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.
- Conditions
- Mitral Valve (MV) Regurgitation
- Being tested
- Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve systemDevice
Trans-catheter, trans-septal mitral valve replacement.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm study | Experimental | Single-arm, group sequential, prospective, multicenter, global, open-label study for the investigation of the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (SMVR) System. The HighLife TSMVR system is intended for use for percutaneous mitral valve replacement via trans-septal access in patients suffering from symptomatic moderate-to-severe or severe functional (secondary) mitral regurgitation (MR). Receives: Device: Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality or heart failure (HF) hospitalization
The rate of all-cause mortality or heart failure (HF) hospitalization at 24 months post-implant.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start30 Dec 2025 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve (MV) 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
- 240 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
- NCT06683729
- Sponsor's protocol ID
- HL-2024-01-Pivotal
- Acronym
- HIGHFIVE
- Status last verified
- Sep 2025
- First submitted
- 7 Nov 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HighLife Clarity Treatment of Severe Mitral Regurgitation
- ClinicalTrials.gov ID
- NCT06683729
- Acronym / sponsor ID
- HIGHFIVE / HL-2024-01-Pivotal
- Conditions
- Mitral Valve (MV) Regurgitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- HighLife SASIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2034 (estimated)
- First posted
- 12 Nov 2024 (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.
The purpose of the study is to evaluate the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (TSMVR) system in NYHA Class ≥ II-IV patients with moderate-to-severe or severe mitral regurgitation (MR) who, by assessment of the local Heart Team, are unsuitable for treatment with approved transcatheter repair (sub-optimal results to complex or prohibitive edge-to-edge repair) or surgical mitral valve intervention according to guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm study | Experimental | Device: Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve systemSingle-arm, group sequential, prospective, multicenter, global, open-label study for the investigation of the safety and effectiveness of the HighLife transcatheter trans-septal mitral valve replacement (SMVR) System. The HighLife TSMVR system is intended for use for percutaneous mitral valve replacement via trans-septal access in patients suffering from symptomatic moderate-to-severe or severe functional (secondary) mitral regurgitation (MR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Based on local regulations, the subject meets the legal minimum age to provide informed consent
- Moderate-to-severe or severe symptomatic MR (≥3+) by transthoracic echocardiography (TTE) which is primarily due to lack of mitral leaflet coaptation, secondary to either a) LV cardiomyopathy with restriction of the mitral leaflet(s), or b) mitral annular dilatation due to chronic atrial fibrillation or other cause, as confirmed by the echocardiographic core laboratory (note: some element of primary (degenerative) MR may be present, but the core lab must agree that the principal etiology is secondary MR)
- New York Heart Association (NYHA) functional class II, III or ambulatory IV
- Based on the assessment of the local multidisciplinary heart team, the patient is:
Key exclusion criteria (10 listed)
- Any stroke or TIA within 30 days prior to procedure; any prior intracranial hemorrhage at any time; or any intracerebral mass, arteriovenous fistula or other malformation or defect predisposing to bleeding
- Known severe carotid stenosis (>70% diameter stenosis by non-invasive imaging) or carotid stenting or carotid endarterectomy within 30 days)
- History of bleeding diathesis, coagulopathy, clotting disorder, or refusal of future blood transfusion or bleeding in the 3 months prior to procedure other than minor cutaneous bleeding
- Patients in whom transesophageal echo (TEE) is not feasible
- Chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or chronic outpatient oral steroid use.
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 |
|---|---|---|
| Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve systemTrans-catheter, trans-septal mitral valve replacement. | Device | Single-arm study |
Primary outcome
All-cause mortality or heart failure (HF) hospitalization
Time frame: 24 months
The rate of all-cause mortality or heart failure (HF) hospitalization at 24 months post-implant.
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 15 Sep 2025.
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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.
Prof Stephen Brecker, MD Chief Medical Office, HighLife contact
Questions about this trial
What is this clinical trial studying?
A study testing Trans-septal (TS) Mitral Valve Replacement (TSMVR) Valve system in people with Mitral Valve (MV) Regurgitation, run by HighLife SAS.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Prof Stephen Brecker, MD Chief Medical Office, HighLife (+33 6 68 77 34 77, sbrecker@highlifemed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality or heart failure (HF) hospitalization (time frame: 24 months). 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 15 Sep 2025.