Clinical trial NCT04888247: HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Regurgitation
Lead sponsor: HighLife SAS
Sponsor class: INDUSTRY
First posted: 2021-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Moderate-severe or severe mitral regurgitation (≥ 3+)
3. Patient has New York Heart Association (NYHA) Functional Class II, III or ambulatory IV
4. Patient is under guideline directed medical therapy for at least one month, as reviewed and confirmed by the local multidisciplinary Heart Team
5. 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
6. Patient meets the anatomical criteria for HighLife valve
7. Patient is willing to participate in the study and provides signed informed consent
8. Patients with a high risk for LVOTO

Exclusion Criteria:

1. Any stroke/TIA within 30 days
2. Severe symptomatic carotid stenosis (\> 70% by non-invasive imaging)
3. Active infections requiring antibiotic therapy
4. Active ulcer or gastro-intestinal bleeding in the past 3 months
5. History of bleeding diathesis, coagulopathy or refusal of future blood transfusion
6. Patients in whom TEE is not feasible
7. Patients who are pregnant or lactating, or plan to get pregnant in the next 12 months.
8. Patient is unable to comply with the follow-up schedule and assessments
9. Participation in another clinical investigation at the time of inclusion
10. Patient has known allergies to the device components or contrast medium
11. Patient cannot tolerate anticoagulation or antiplatelet therapy
12. Patients with a life expectancy of less than 12 months due to non-cardiac conditions
13. Patient had permanent pacemaker, or similar device with implantable cardiac leads (i.e. resynchronization therapy) within the last 3 months

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Primary outcomes:
measure: Rate of subjects meeting Technical Success
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Auchenflower
country: Australia
facility: Wesley Hospital
city: Perth
country: Australia
facility: Mount Hospital
city: Sydney
country: Australia
facility: Macquarie University Hospital
city: Brugge
country: Belgium
facility: AZ St. Jan - Brugge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lille
country: France
facility: CHU Lille
city: Nantes
country: France
facility: Centre Hospitalo - Univ de Nantes
city: Rennes
country: France
facility: CHU de Rennes
city: Toulouse
country: France
facility: Cliniue Pasteur
city: Munich
country: Germany
facility: Deutsches Herzzentrum Munchen
city: Ulm
country: Germany
facility: University Hospital Ulm
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Warsaw
country: Poland
facility: Medical University of Warsaw
city: Brighton
country: United Kingdom
facility: Brighton and Sussex University Hospital
Study officials:
References: