Heart failure due to ischemic cardiomyopathy Circulatory System Ischaemic cardiomyopathy
Conditions
Interventions
Participants receive ventricular reduction as part of their standard care. Prior to the operation, Cardiac Magnetic Resonance or Cardiac Tomography shall be used (according to institutional practice)
Sponsors
BioVentrix, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased ventricular volume and anteroseptal or apical scar Additional general inclusion criteria: 2. Subject is >18 years of age 3. Subject is able and willing to provide written informed consent 4. Subject is on guideline directed medical therapy (GDMT) for heart failure
Exclusion criteria
Exclusion criteria: 1. Inadequate myocardial viability in regions remote from the scar 2. Thrombus or intra-ventricular mass 3. Cardiac Resynchronization Therapy (CRT) 4. Patient intolerance or unwillingness to take anti-coagulation medication 5. Functioning pacemaker leads in antero-apical RV 6. Pulmonary Arterial Pressure > 60 mm Hg 7. Myocardial Infarction less than 90 days before the procedure 8. Previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement 9. Chronic renal failure with a serum creatinine >2 mg/dL 10. Inoperable coronary disease with significant ischemia 11. Pulmonary disease that would preclude transient single lung ventilation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Decrease in Left Ventricular volume is measured using echocardiography at 6 months, 1, 2, 3, 4 and 5 years. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in heart failure status assessed by Left Ventricular Ejection Fraction, New York Heart Association class, quality of life assessment, and walking distance as measured by a 6-minute walk exam at baseline, 6 months, 1, 2, 3, 4 and 5 years. | — |
Countries
Czech Republic, Germany, Italy, Switzerland
Contacts
Public ContactNoel Messenger
Outcome results
None listed