Heart failure ischemic cardiomyopathy
Conditions
Interventions
None listed
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patient is male or female 18 years or older. * Patient is diagnosed with ischemic cardiomyopathy. I.e. a significantly impaired left ventriculair dysfunction (left ventricular ejection fraction * 35 to 40 percent) that results from coronary artery disease based on a coronary angiogram. * Patient has documented myocardial segments with reversible ischemia and or hibernation. * Patient is classified as NYHA class II-IV. * Patient should be on a stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. * Patients where angioplasty and bypass are not indicated because of anatomical or procedural reasons or frequent reocclusion / restenosis following traditional revascularization. * Patient has refused to undergo another angioplasty or CABG.
Exclusion criteria
Exclusion criteria: * Patient has chronic lung disease including emphysema and pulmonary fibrosis. * Patient has active endocarditis, myocarditis or pericarditis. * Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization. * Patients who are unwilling or unable to cooperate with study procedure. * Patients with renal dysfunction with eGFR
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in myocardial blood flow and occurrence of reverse remodeling after treatment of patients with Ni-Cath based on MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints consist of wall motion abnormalities, left ventricular function, and improvement in NYHA class based on MRI and Quality Of Life score. | — |
Countries
Netherlands
Outcome results
None listed