NCT04029363RecruitingNot Applicable
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
HighLife SAS90 sites in 7 countries120 target enrollmentStarted: May 28, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 90
- Primary Endpoint
- Device Safety
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •1. 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, as reviewed and confirmed by the local multidisciplinary Heart Team, for at least one month
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Device Safety
Time Frame: 30 days
Freedom from major adverse events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (90)
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