AltaValve Pivotal Trial

Launched by 4C MEDICAL TECHNOLOGIES, INC. · Jun 13, 2024

Keywords

ClinConnect Summary

The AltaValve Pivotal Trial is a study looking at the safety and effectiveness of a new device called the AltaValve System for treating mitral regurgitation, a condition where the heart's mitral valve doesn't close properly, causing blood to flow backward. This trial is currently recruiting participants who are aged 18 and older and have moderate to severe symptoms despite receiving the best available medical treatment. To be eligible, participants should not be candidates for traditional surgery or other less invasive procedures due to their specific health conditions.

If you or someone you know is considering participating, you can expect to receive close monitoring throughout the trial to ensure safety and track the treatment's effects. It's important to note that certain individuals may not qualify, such as those with severe heart issues, recent heart surgeries, or those who are pregnant. Overall, this trial aims to provide more options for patients with significant heart valve problems who might not have many alternatives.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria (Abbreviated List):
• • 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 index procedure.
• • Percutaneous coronary intervention (PCI) within 90 days prior to the index procedure.