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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.
Enrollment
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Inclusion criteria
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
Primary purpose
Allocation
Interventional model
Masking
120 participants in 1 patient group
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Central trial contact
Martin Rothman, MD
Data sourced from clinicaltrials.gov
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