Lindner Research Center | The Christ Hospital

Drug/Device Information
Parachute Implant is an implantable partitioning membrane device deployed within the compromised ventricle
The Parachute Implant isolates the dysfunctional region of the ventricle and decreases functional chamber volume.
Randomized 1:1 to Parachute Implant and all appropriate medical therapy (AAMT) vs. AAMT
CardioKinetix, Inc.

Parachute Implant is an implantable partitioning membrane device deployed within the compromised ventricle

The Parachute Implant isolates the dysfunctional region of the ventricle and decreases functional chamber volume.

Randomized 1:1 to Parachute Implant and all appropriate medical therapy (AAMT) vs. AAMT

CardioKinetix, Inc.

Major Inclusion and Exclusion
Symptomatic ischemic heart failure (NYHA Class III or “ambulatory” Class IV) > 60 days post MI in the LAD territory
Age ≥ 18 and ≤ 79 years and BMI < 40
EF ≥ 15% and ≤ 35% and no pacemaker, ICD, or CRT within 60 days
No Hemoglobin < 10 g/dl (female) or < 12 g/dl (male) or Creatinine > 2.5mg/dl

Symptomatic ischemic heart failure (NYHA Class III or “ambulatory” Class IV) > 60 days post MI in the LAD territory

Age ≥ 18 and ≤ 79 years and BMI < 40

EF ≥ 15% and ≤ 35% and no pacemaker, ICD, or CRT within 60 days

No Hemoglobin < 10 g/dl (female) or < 12 g/dl (male) or Creatinine > 2.5mg/dl

Heart Failure