StudyFinder
Atlas Pivotal Trial
Status: Recruiting
This study aims to assess the safety and effectiveness of the AltaValve System in treating patients with mitral regurgitation, a condition where the heart's mitral valve does not close tightly, allowing blood to flow backward in the heart. It focuses on patients who cannot undergo surgery or Transcatheter Edge-to-Edge Repair (TEER).
Sex: Male or Female
Age: 18 years and over
Healthy Volunteers:
Inclusion Criteria:
18 years of age or older.
• Has symptoms from heart failure that range from mild limitations during normal activities to severe symptoms even at rest
• Significant leakage of the mitral valve rated as moderate-to-severe or severe
• Is not a good candidate for standard mitral valve procedures
Exclusion Criteria:
• Significant aortic valve, tricuspid valve, or pulmonic valve disease.
• Severe blockage in one or both of the major neck arteries
• Severe COPD or interstitial lung disease or home oxygen use.
• Severe kidney disease, including kidney failure requiring dialysis
• Active cancer (except cancer that is low grade, maintained or in-remission)
• Very high blood pressure
• Inability to walk at least 100 meters in 6 minutes
• Expected to live less than a year due to another major medical condition.
Interventions:
Drug/Device: AltaValve System
Conditions:
Mitral Regurgitation, Mitral Annular Calcification, Mitral Stenosis, Mitral Insufficiency
Keywords:
Mitral Valve Insufficiency, Transcatheter Mitral Valve Replacement
Contact(s): Darla Washington - dwashi19@hfhs.org
Principal Investigator: Brian O'Neill
Principal Investigator ID: boneil3@hfhs.org
Phase: N/A
See this study on ClinicalTrials.gov