ATLAS
The ATLAS study evaluates the safety and performance of an investigational replacement heart valve system for the treatment of mitral regurgitation.
About This Study
Summary
Mitral regurgitation is the most common form of heart valve disease worldwide. The mitral valve is located in the upper left chamber of the heart and is designed to act as a one-way door for blood flow. However, sometimes this door does not close tightly, allowing blood to leak backwards (regurgitation). When the mitral valve fails to close completely, the heart must work harder to pump enough blood to the body.
The standard treatment for mitral regurgitation is transcatheter mitral valve replacement (TMVR). In this procedure, a cardiologist directs a thin, flexible tube (catheter) through a blood vessel and into the heart. The cardiologist then uses the catheter to deliver a replacement value, placing it directly over the damaged one. The device investigated in ATLAS has been designed to further minimize the complications that infrequently occur during or after TMVR. Overall, the ATLAS study evaluates the safety and performance of the investigational replacement heart valve system for the treatment of mitral regurgitation. For participants in the ATLAS study, the investigational device is delivered through a catheter to the mitral valve area of the heart. Members of the research team will contact participants to schedule assessments at 30 days, 6 months, and 1 year after device placement. In addition, participants undergo annual follow-up exams during years 2 through 5.
To be included in ATLAS, participants must be / have
- Adult (aged 18 years old or older)
- Symptomatic heart failure, defined as New York Heart Association (NYHA) class II–IV
- Moderate-to-severe mitral regurgitation despite optimal guideline-directed medical therapy
- Unsuitable for surgery and transcatheter edge-to-edge repair (TEER), as determined by the local site heart team
To be included in ATLAS, participants must not be / have
- Current left ventricular ejection fraction (LVEF) of ≤25%
- Transcatheter aortic repair or replacement within 90 days before the index procedure
- Percutaneous coronary intervention (PCI) within 90 days before the index procedure
Keywords
Heart disease; Mitral regurgitation; TMVR; Transcatheter mitral valve replacement
For More Information or To Ask About Participation
Additional Information
Lead scientist at Carilion Clinic
Jason Foerst, MD, is the medical director of the Structural Heart and Valve Center at Carilion Clinic, assistant professor of medicine at Virginia Tech Carilion School of Medicine, and director of Carilion's structural heart disease fellowship program. Dr. Foerst is a structural interventional cardiologist and researcher who completed his internship, residency, and fellowship training at Dartmouth–Hitchcock/Mary Hitchcock Memorial Hospital.
Official title of study
The AltaValve Pivotal Trial
Funding mechanism
Industry sponsored by 4C Medical Technologies