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Study Status: 
Open
Study Description: 

Enrollment in this trial is temporarily on hold.

This clinical trial is for men and women who are diagnosed with ischemic or congestive heart failure (CHF) after a myocardial infarction (MI or “heart attack”).  

The purpose of the study is to assess the efficacy and long-term safety of the CardioKinetix Parachute device, an umbrella-shaped membrane that is is implanted inside the left ventricle of the heart. This creates a partition in the ventricle, reducing the effective size of the chamber and restoring its natural shape somewhat, which has been shown to be important for the treatment of heart failure. It is implanted with a catheter procedure, avoiding the risks of surgery.

Study subjects will be followed up for 5 years after placement of the stent.

Key Eligibility: 

Men and women between 18 and 79 years old with:

  • Symptomatic heart failure in NYHA class III or IV (ambulatory)
  • Myocardial infarction at least 60 days prior to enrollment that resulted in structural heart dysfunction (“LV wall motion abnormality”)
  • Left ventricular (LV) systolic dysfunction (LVEF between 15% and 35%)
  • Body Mass Index (BMI) ≤ 40

Additional assessments will determine surgical risk.

Detailed eligibility requirements will be reviewed when you contact the study team.

Principal Investigator: 
Evelyn Horn, M.D.
Contact: 

Melissa D. Ricketts, CCRC, phone 212-746-2698, email mdr2001@med.cornell.edu

Dolores Reynolds, R.N., phone 212-746-4617, email dtr2001@med.cornell.edu.

Sponsor: 
CardioKinetix, Inc.
Official Title: 

Percutaneous Ventricular Restoration in Chronic Heart Failure Due to Ischemic Heart Disease. ClinicalTrials.gov Identifier NCT01614652

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