RecruitingNot ApplicableNCT04888247
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
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)
Sponsor
HighLife SAS
Enrollment
30 participants
Start Date
Jul 1, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria14
- 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
- \-
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DEVICECLARITY
Trans-septal mitral valve replacement
Locations(14)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04888247
Related Trials
A Clinical Study of GeminiOne TEER System for the Treatment of Severe, Symptomatic MR.
NCT070865341 location
Cephea Early Feasibility Study
NCT0506100422 locations
Abbott Cephea Mitral Valve Disease Registry
NCT0706967319 locations
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant
NCT070071431 location
STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients With an Indication for Oral Anticoagulant
NCT069014661 location