Mitral Regurgitation
Conditions
Brief summary
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
Interventions
DEVICEHighLife Transcatheter Mitral Valve Replacement
Transcatheter Mitral Valve Replacement
Sponsors
ICON plc
HighLife SAS
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month 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
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Safety | 30 days | Freedom from major adverse events |
Countries
Australia, Belgium, France, Germany, Poland, Singapore, United Kingdom
Contacts
Primary ContactMartin Rothman, MD
Outcome results
None listed