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

This is an interventional treatment trial for Diastolic Heart Failure NYHA Class III-IV focused on measuring Heart Failure with Preserved Ejection Fraction (HFpEF), Diastolic Heart Failure (DHF), Diastolic Dysfunction (DD) Read More

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