CORolla™ TAA for Heart Failure and Preserved Ejection Fraction and Diastolic Dysfunction

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