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HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve

RECRUITING

Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system.

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

Exclusion criteria

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-07-01

Primary completion: 2025-12-01

Study completion finish: 2031-02-01

Study type

TREATMENT

Phase

Trial ID

NCT04888247

Intervention or treatment

DEVICE: CLARITY

Conditions

• Mitral Regurgitation

Condition: Mitral Regurgitation
DEVICE: CLARITY
Auchenflower, Not Specified, Australia and more
Sponsor: HighLife SAS

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Wesley Hospital

Research sites nearby

Select from list below to view details:

Wesley Hospital
Auchenflower, Not Specified, Australia
Mount Hospital
Perth, Not Specified, Australia
Macquarie University Hospital
Sydney, Not Specified, Australia

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?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment Trans-septal mitral valve replacement	DEVICE: CLARITY Trans-septal mitral valve replacement

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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	24 hours

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve