SHS_300253 HUAP CCKX 12088

Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease

Treatment of ischemic heart failure.

Inclusion Criteria:
•Body Mass Index (BMI) ≤ 40.
•Symptomatic ischemic heart failure (New York Heart Association (NYHA) Class III or 'ambulatory' Class IV as determined through the use of the SAS) post Myocardial Infarction (MI) in the Left Anterior Descending (LAD) territory at least 60 days prior to enrollment.
•Patient is not hospitalized at the time of enrollment.
•Receiving appropriate medical treatment for heart failure according to the current American College of Cardiology (ACC)/American Heart Association (AHA) Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three months prior to enrollment.
Inclusion Criteria based on Imaging: 15% ≤ Left Ventricular Ejection Fraction (LVEF) ≤ 35% by Transthoracic Echocardiogram (TTE); Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by TTE; Left ventricle must have appropriate anatomy (size and morphology) for implant placement using Cardiac Computed Tomography (CT) and confirmed by LV gram

Exclusion Criteria:
•Untreated clinically significant coronary artery disease requiring revascularization.
•Cardiogenic shock within 72 hours of enrollment.
•Patient has received a pacemaker, Implantable Cardioverter Defibrillator (ICD), or Cardiac Resynchronization Therapy (CRT) within 60 days of enrollment.
•Excessive wall motion abnormalities outside the anteroapical region.
•Recent (within 6 months) cerebrovascular accident (CVA) or transient ischemic attack (TIA).
•End stage renal disease requiring chronic dialysis.
•Obstructive Sleep Apnea (OSA) unless compliant on CPAP therapy or successful surgery.
•Hemoglobin < 10 g/dl (female), < 12 g/dl (male) or Creatinine > 2.5mg/dl.
•Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
•Active peptic ulcer or GI bleeding within the past 3 months.
•A known hypersensitivity or contraindication to aspirin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre-medicated.
•Ongoing sepsis, including active endocarditis
Anatomical Exclusion Criteria: Pre-existing prosthetic heart valve in mitral or aortic position; Valvular stenosis or regurgitation (tricuspid, aortic or mitral) > 2+; Presence of anatomic anomalies (including severe calcification) detected by cardiac imaging (echocardiogram, Computed Tomography (CT), or LV gram) preventing unimpeded deployment and/or operation of the Parachute Implant
Phase III
NCT01614652
Heart and Vascular, All Other
Heart Failure
Paul Huang, M.D.
CardioKinetix
  • Swedish Medical Center