PARACHUTE IV

A MULTINATIONAL TRIAL TO EVALUATE THE PARACHUTE IMPLANT SYSTEM: PARACHUTE PercutAneous Ventricular RestorAtion in Chronic Heart FailUre Due to Ischemic HearT DiseasE

PARACHUTE IV [NCT01286116]

Description: The primary objective is to assess the safety of the CardioKinetix Parachute Implant and Delivery System in the partitioning of the left ventricle in patients with heart failure due to ischemic heart disease.

 

Device: PARACHUTE implant; Control: All appropriate medical therapy


Primary Investigator: Chung

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.
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