What is the purpose of a clinical study?
Clinical studies are research studies that are designed to establish the safety, performance and/or effectiveness of investigational medical products and procedures. Read more about the REDUCE LAP-HF II study at www.clinicaltrials.gov.
What is the IASD® System II?
IASD system II, an investigational, non-surgical, medical device designed to improve symptoms and quality of life by reducing breathlessness and fatigue.
How is the IASD System II placed?
The IASD System II is placed by an interventional cardiologist using a standard non-surgical procedure. During the procedure, a catheter is used to create a very small opening in the heart wall between the left and right atria to allow placement of the implant. The implant is then placed in the opening to keep it open over time, and allows blood to flow between the two chambers from the high pressure left side to the low pressure right side, lowering the high pressure in the left atrium, which contributes to the symptoms of heart failure.
Who can participate?
If you are 40 years old or older, have chronic symptoms of heart failure, and meet study criteria, you may be a candidate for the study.
What company is sponsoring the study?
The clinical study is being sponsored by Corvia Medical, Inc., a US medical device company dedicated to revolutionizing the treatment of heart failure with first-in-class structural heart devices. For more information on the company, visit www.corviamedical.com.