A Pivotal Trial to Establish Efficacy and Long-Term Safety of the Parachute Implant System
To evaluate the reasonable assurance of safety and effectiveness of the CKI Parachute implant in the treatment of patients with NYHA Class III or IV (AMBULATORY) heart failure due to ischemic heart disease.
Heart & Vascular - Interventional Cardiology Trials
Paul Huang, MD
Subjects must be 18-79 years of age, with a BMI of 40 or less. They must have a diagnosis of symptomatic ischemic heart failure (NYHA Class III or “ambulatory” Class IV) post MI in the LAD territory at least 60 days prior to enrollment, and must not be hospitalized at the time of enrollment. The LVEF must be between 15% and 35%, as established by TTE.
Charlene Boisjolie and Christine Goetz