Status:
RECRUITING
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
Lead Sponsor:
HighLife SAS
Collaborating Sponsors:
ICON plc
Conditions:
Mitral Regurgitation
Eligibility:
All Genders
18+ years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
May 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2031
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04029363
Start Date
May 28 2019
End Date
December 15 2031
Last Update
September 15 2025
Active Locations (50)
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1
St. Vincent's Hospital - Sydney
Darlinghurst, New South Wales, Australia, 2010
2
John Hunter Hospital
Newcastle, New South Wales, Australia, 2305
3
Macquarie University Hospital
Sydney, New South Wales, Australia, 2109
4
The Wesley Hospital
Auchenflower, Queensland, Australia, 4066