PercutAneous Ventricular RestorAtion In Chronic Heart failure due to Ischemic HearTDiseasE-III - PARACHUTE III

CardioKinetix Inc.0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年4月29日

适应症

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•*Akinesis or dyskinesis due to myocardial infarction limited to anteroapical region
•* Subject is not hospitalized at time of enrollment.
•* NYHA Class at time of enrollment, either:
•NYHA Class III or Ambulatory IV * if predominant during the 3-month period prior to enrollment
•NYHA Class II * if diagnosed with NYHA Class III or IV during 3-month period prior to enrollment
•* LVEF >15% and* 40% as measured by echocardiography.
•* Post LV MI structural heart dysfunction represented by LV wall motion abnormality (WMA) by
•echocardiography.
•* Receiving appropriate medical treatment for heart failure according to the ACC/AHA 2009 Guideline
•- Update for the Diagnosis and Management of Chronic Heart Failure in the Adult during the three
•months prior to enrollment

•* Untreated clinically significant coronary artery disease requiring intervention.
•* 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
•* History of aborted sudden cardiac death, if patient has not received an ICD and has potentially lethal ventricular arrhythmia, VT or VF
•* Aortic valve replacement or repair
•* Blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.
•* Active peptic ulcer or GI bleeding within the past 3 months
•* Patient has suffered a cerebrovascular accident (CVA) or transient ischemic attack (TIA) within
•the past 6 months
•* History of Kawasaki*s disease
•* Ongoing sepsis, including active endocarditis.
•* Anatomical characteristics not suitable for treatment with the Parachute Implant device as
•screened by the echocardiography core lab. (characteristics include inappropriate size and shape
•of the left ventricle, presence of LV apical thrombus, pseudo chordae or trabeculations)

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