CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)
CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)
The study objective is to demonstrate safety and feasibility of the CORolla® TAA during 12
 months of follow up, and to evaluate the performance of the therapy in relieving symptoms and
 restore diastolic function in patients with heart failure and preserved ejection fraction.
Inclusion Criteria

 Clinical criteria:

 1. Adult (age > 18 years)

 2. Diagnosis of heart failure with preserved ejection fraction

 3. NYHA F. Class III or IV or documented history of at least two heart failure
 hospitalization in the past year prior to enrollment.

 4. No contraindication for anticoagulation and antiplatelet treatment.

 5. Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks
 (not including diuretics)

 6. Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at
 enrollment.

 7. Patient understands the study requirements and the treatment procedures and provides
 written Informed Consent before any study-specific tests or procedures are performed

 8. Patient is able and willing to adhere to the required follow-up visits and testing

 9. Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole

 Echocardiographic criteria:

 1. Left ventricular ejection fraction≥50%

 2. HFpEF diagnosis according to ESC 2016 guidelines

 3. No evidence of intra-cardiac thrombus

 Cardiovascular disease:

 1. Implanted or planned implantation of defibrillator devices such as ICD cardiac
 resynchronization device (CRT-D) or left ventricular assist device (LVAD).

 2. Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular
 accident (CVA), or Transient Ischemic Attack (TIA).

 3. History of thrombus within the previous 3 months.

 4. Coronary Artery Bypass Surgery (CABG), valve replacement or repair, aortic surgery or
 percutaneous coronary intervention (PCI in the past 3 months or planned/anticipated
 within the coming 6 months. Patients with mechanical valve replacement or CABG
 performed more than 3 months before may be eligible for enrollment.

 5. Significant valvular disease classified as

 -  Moderate or severe aortic stenosis/regurgitation

 -  Moderate or severe mitral stenosis

 -  Severe mitral regurgitation

 6. Hypertrophic cardiomyopathy

 7. History of pericardial disease.

 8. HF attributed to Cor pulmonale or other cause of isolated right heart failure.

 9. Moderate to severe right ventricle failure or right ventricular myocardial infarction.

 10. Infiltrative heart disease including amyloidosis.

 Non-cardiovascular disease:

 1. Prior surgery, radiation, or thoracic surgery limiting the ability to place the
 device.

 2. Moderate to severe asthma or COPD, or severe restrictive lung disease.

 3. Severe chronic renal failure indicated by MDRD GFR <30 mL/min/1.73 m2.

 4. Liver impairment addressed by bilirubin > 2 mg/dl and serum albumin <3 g/dL

 5. Severe anemia addressed by Hb concentration <9 gr/l.

 6. Solid organ or hematologic transplant.

 7. Previous Trans Apical procedures/implantation.

 Miscellaneous conditions:

 1. Co-morbid condition that in the physician's opinion would prohibit the subject's
 ability to meet the protocol requirements.

 2. Pregnancy at the time of enrollment. (Women of childbearing potential must have a
 negative serum pregnancy test within two weeks prior to enrollment, or be using
 hormonal contraceptives or intrauterine devices).

 3. Participating in another treatment investigational study.

 4. 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.