A Multinational Trial To Evaluate The Parachute Implant System (NCT01286116) | Clinical Trial Compass
TerminatedPhase 3
A Multinational Trial To Evaluate The Parachute Implant System
Stopped: Company closed
France, Germany, Latvia59 participantsStarted 2011-05
Plain-language summary
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.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
✓. Subject is not hospitalized at time of enrollment.
✓. Diagnosis of heart failure for a minimum of 6 months prior to enrollment
✓. NYHA Class at time of enrollment, either:
✓. LVEF \>15% and ≤ 40% as measured by echocardiography.
✓. Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by echocardiography.
✕. Acute MI (see MI definition) within 60 days of enrollment or patients with suspected evolving MI at time of enrollment
✕. Cardiogenic shock within 72 hours of enrollment
✕. Revascularization procedure (PCI or CABG) within 60 days of enrollment
✕. Patient has received a pacemaker, ICD, or CRT device within 60 days of enrollment
✕
What they're measuring
1
The successful delivery and deployment of the Parachute Implant through 6-month follow-up without the occurrence of Major Adverse Cardiac Events (MACE)
. Moderate aortic stenosis and regurgitation (aortic or mitral) \>2+.
✕. History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
✕. A known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.