PARACHUTE Trial Research

 

PARACHUTE Trial (Currently in Follow-Up)

PARACHUTE is a dual-arm (PARACHUTE vs OMT), open-label, multi-center trial designed to evaluate the PARACHUTE implant that enrolled 19 patients in Cohort A and will enroll up to 80 patients in Cohort B with ischemic heart failure in 14 centers across Europe. The primary endpoint is device related MACE at 6 months. Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

 

PARACHUTE US Feasibility Trial (Currently in Follow-Up)

PARACHUTE US Feasibility is a single-arm, open-label, multi-center trial designed to evaluate the PARACHUTE implant that enrolled 20 patients with ischemic left side heart failure at 8 centers in the U.S. The primary endpoint is device related MACE at 6 months. Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

 

PARACHUTE III Trial (Currently in Follow-Up)

PARACHUTE III is a dual-arm (PARACHUTE vs OMT), open-label, multi-center trial designed to evaluate the PARACHUTE implant that will enroll up to 100 patients with ischemic heart failure in up to 20 centers in Europe. The primary endpoint is procedural and device related MACE through 60 months. Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

 

PARACHUTE IV Trial (Enrolling)

PARACHUTE IV is a randomized (1:1, PARACHUTE vs OMT), multi-center trial designed to evaluate the PARACHUTE implant that will enroll approximately 560 patients with ischemic heart failure in up to 80 centers in the U.S. The event driven primary endpoint includes all-cause mortality and hospitalization for worsening heart failure. Other key endpoints include hemodynamic measures by echocardiography (ECHO) and imaging measures by computed tomography (CT).

 

PARACHUTE China Trial (Currently in Follow-Up)

PARACHUTE China is a single-arm, open-label, multi-center trial designed to evaluate the PARACHUTE implant that enrolled 31 patients with ischemic heart failure at 7 centers in China. The primary endpoint is LVESVi reduction at 3 months. Other key endpoints include assessments in functional status and quality of life.

 

PARACHUTE V Trial (Enrolling)

PARACHUTE V is a dual-arm (PARACHUTE vs OMT), open-label, multi-center trial designed to evaluate the PARACHUTE implant that will enroll up to 130 patients with ischemic heart failure in up to 20 centers in Germany. The primary endpoint is improvement in quality of life at 6 months, and the secondary endpoint is improvement in acute stroke volume index.