RecruitingNot Applicable

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

Australia, Belgium30 participantsStarted 2021-07-01

Plain-language summary

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

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

Rate of subjects meeting Technical Success

Timeframe: 24 hours

NCT IDNCT04888247

SponsorHighLife SAS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-01

Luc Verhees

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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