corolla™ taa for heart failure and preserved ejection fraction and diastolic dysfunction

Conditions: Diastolic Heart Failure NYHA Class III-IV; Diastolic Dysfunction Secondary to Aortic Stenosis

Summary: the study purpose is to evaluate the safety and feasibility of the corolla™ taa in two treatment groups, "corolla™ stand-alone group" and " avr \& corolla™ add on group".


Eligibility criteria:
inclusion criteria: * clinical criteria * adult (age \> 18 years) * diagnosis of heart failure with preserved systolic function according with esc 2008 guidelines (ejection fraction ≥ 50%) * nyha f. class iii or iv symptoms with history of previous heart failure hospitalization in the last year * able to sign informed consent and return for follow-up visits. * no contraindication for anticoagualation and antiplatelet treatment. * cardiac medications unchanged for greater than 4 weeks (not including diuretics) * pulmonary wedge pressure \> 15 mmhg documented by right heart catheterization at enrollment. * echocardiographic criteria * preserved regional wall motion (no wall motion abnormalities). * left ventricular ejection fraction ≥ 50% * lv end-diastolic volume index (lvedvi) \<97 ml/m2. * left atrial volume index: (lavi \>29 ml/m2). * e/e' ratio ( mean of septal and lateral ) ≥12 (applicable only to patients with sinus rhythm) * no intra-cardiac thrombus. * minimal endocardial height from apex to mitral annulus ≥ 70mm. exclusion criteria: * cardiovascular disease * uncontrolled htn defined as \> 140/90 mmhg, or \>160/90 mmhg for patients on 3-drug therapy * current or anticipated need for icd, currently implanted with a cardiac resynchronization device (crt), left ventricular assist device (lvad). * within the past 3 months - acute myocardial infarction (ami), cerebral vascular accident (cva), transient ischemic attack (tia) , percutaneous coronary intervention (pci or transmyocardial laser revascularization (tmr or pmr) * valvular disease (unless add - on to aortic valve replacement due to aortic stenosis) * hypertrophic cardiomiopathy * pericardial disease * cor pulmonale or other cause of isolated right heart failure. * non reversible pulmonary hypertension. * right ventricle failure or right ventricular myocardial infarction. * infiltrative heart disease * non-cardiovascular disease * non-cardiovascular condition limiting ability to assess the 6-minute hall walk test * prior surgery, radiation, or thoracic surgery limiting the ability to place the device * body mass index of greater than 40 * uncontrolled hyperglycemic status as addressed by hba1c \>8.5% * asthma copd (e.g. fev1 \<1.5 liter), or severe restrictive lung disease * severe chronic renal failure indicated by mdrd gfr \<30 ml/min/1.73 m2 * liver impairment addressed by bilirubin \> 2 mg/dl and or pseudo- colinesterasis plasma concentration \< 1500 iu and/or abnormal coagulative profile * severe anemia addressed by hb concentration \<10 gr/l. * solid organ or hematologic transplant. * previous trans apical procedures/implantation * miscellaneous conditions * unwilling to fulfill the protocol medication compliance, testing, and follow-up requirements * co-morbid condition that in the physician's opinion would prohibit the subject's ability to meet the protocol requirements * pregnancy at the time of enrollment. (women of child bearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices) * enrolled in another investigational study * a history of alcohol abuse, drug addiction, or other psychosocial condition that would preclude successful participation, or clear judgment and informed consent in the opinion of the principal investigator

Keywords: heart failure with preserved ejection fraction (hfpef) diastolic heart failure (dhf) diastolic dysfunction (dd)