Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
4C Medical Technologies, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age ≥ 18 years.
Symptomatic New York Heart Association (NYHA) class II-IV.
Moderate-to-severe or severe MR (3+) despite optimal guideline-directed medical therapy (GDMT) as determined by an independent Echo Core Lab.
Unsuitable for surgery and Transcatheter Edge-toEdge Repair (TEER) as determined by the local site Heart Team.
You may not be if
Inability to understand the trial or a history of non-compliance with medical advice.
Inability to provide signed Informed Consent Form (ICF).
History of any cognitive or mental health status that would interfere with participation in the trial.
Currently enrolled in any other pre-approval investigational trial (does not apply to long-term post-market trials unless these trials might clinically interfere with the current trial endpoints (e.g., limit use of trial-required medication, etc.)).
Female subjects who are pregnant or planning to become pregnant within the trial period.
Known hypersensitivity or contraindication to heparin, or warfarin without adequate alternative medications.
Known hypersensitivity to nitinol (i.e., nickel allergy) that cannot be adequately medicated.
Known hypersensitivity to contrast media that cannot be adequately medicated.
Evidence of current left ventricular ejection fraction (LVEF) ≤ 25%.
Concurrent medical condition with a life expectancy of less than 12 months.
Transcatheter aortic repair or replacement within 90 days prior to the baseline required tests.
Percutaneous coronary intervention (PCI) within 30 days prior to the index procedure.
