HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system.
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).
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
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- NA
Study ID
NCT04888247
Intervention or treatment
DEVICE: CLARITY
Conditions
- Mitral Regurgitation
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Research sites nearby
Closest Location:
Wesley Hospital
Select from list below to view details:
Wesley Hospital
Auchenflower, Australia
Mount Hospital
Perth, Australia
Macquarie University Hospital
Sydney, Australia
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Who is running the clinical trial?
HighLife SAS
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
| Device: CLARITY |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
References
Clinical Trials Gov: HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY ValveOther trials to consider
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