CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)

  • End date
    Sep 25, 2024
  • participants needed
  • sponsor
    CorAssist Cadiovascular Ltd.
Updated on 25 January 2022
ejection fraction
heart failure
heart disease
myocardial infarction
right heart catheterization
diastolic dysfunction
heart failure with preserved ejection fraction


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.

Condition Diastolic Heart Failure, Diastolic Dysfunction
Treatment CORolla™ TAA device
Clinical Study IdentifierNCT02499601
SponsorCorAssist Cadiovascular Ltd.
Last Modified on25 January 2022


Yes No Not Sure

Inclusion Criteria

Clinical criteria
Adult (age > 18 years)
Diagnosis of heart failure with preserved ejection fraction
NYHA F. Class III or IV or documented history of at least two heart failure hospitalization in the past year prior to enrollment
No contraindication for anticoagulation and antiplatelet treatment
Optimal medical cardiovascular pharmacotherapy with stable doses for at least 4 weeks (not including diuretics)
Pulmonary Wedge pressure > 15 mmHg documented by right heart catheterization at enrollment
Patient understands the study requirements and the treatment procedures and provides written Informed Consent before any study-specific tests or procedures are performed
Patient is able and willing to adhere to the required follow-up visits and testing
Minimal endocardial height from Apex to Mitral Annulus > 60mm at end systole
Echocardiographic criteria
Left ventricular ejection fraction50%
HFpEF diagnosis according to ESC 2016 guidelines
No evidence of intra-cardiac thrombus
Cardiovascular disease
Implanted or planned implantation of defibrillator devices such as ICD cardiac resynchronization device (CRT-D) or left ventricular assist device (LVAD)
Within the past 3 months - Acute myocardial infarction (AMI), cerebral vascular accident (CVA), or Transient Ischemic Attack (TIA)
History of thrombus within the previous 3 months
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
Significant valvular disease classified as
Moderate or severe aortic stenosis/regurgitation
Moderate or severe mitral stenosis
Severe mitral regurgitation
Hypertrophic cardiomyopathy
History of pericardial disease
HF attributed to Cor pulmonale or other cause of isolated right heart failure
Moderate to severe right ventricle failure or right ventricular myocardial infarction
Infiltrative heart disease including amyloidosis
Non-cardiovascular disease
Prior surgery, radiation, or thoracic surgery limiting the ability to place the device
Moderate to severe asthma or COPD, 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 serum albumin <3 g/dL
Severe anemia addressed by Hb concentration <9 gr/l
Solid organ or hematologic transplant
Previous Trans Apical procedures/implantation
Miscellaneous conditions
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 childbearing potential must have a negative serum pregnancy test within two weeks prior to enrollment, or be using hormonal contraceptives or intrauterine devices)
Participating in another treatment 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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