Clinical trial NCT02499601: CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD)
Official title: CORolla® TAA for Heart Failure With Preserved Ejection Fraction (HFpEF) and Diastolic Dysfunction (DD) Safety and Feasibility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diastolic Heart Failure
Diastolic Dysfunction
Keywords: Heart Failure with Preserved Ejection Fraction (HFpEF)
Heart Failure (HF)
New York Heart Association functional Class (NYHA f. Cl)
Lead sponsor: CorAssist Cadiovascular Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-16
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with All-cause mortality and Serious Adverse Events (SAEAs)
timeFrame: 6 months
measure: Incidence of in-hospital procedure success.
timeFrame: up ot 24 hour.
Secondary outcomes:
measure: Rate of HF death and re-hospitalization due to HF (including IV diuretic)
timeFrame: 6 months
measure: Rate of HF death and re-hospitalization due to HF (including IV diuretic)
timeFrame: 12 months
measure: Rate, type and severity of procedure related and device-related events
timeFrame: 30 days
measure: Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)
timeFrame: up to 6 months
measure: Change in Quality of Life (QoL) Questionnaire
timeFrame: up to 24 months
measure: Change in New York Heart Association functional Class (NYHA f. Cl).
timeFrame: up to 24 months
measure: Change in exercise capacity as measured by the Six-Minute Walk test.
timeFrame: up to 24 months
measure: Device impact on diastolic dysfunction markers assessed by conventional echocardiography imaging and novel approach including Tissue Doppler Imaging (TDI).
timeFrame: up to 24 months
measure: Change of Wedge pressure
timeFrame: up to 24 months
measure: Change in Pulmonary Capillary Wedge Pressure during handgrip/ergometry
timeFrame: up to 24 months
measure: Change in exercise testing during echocardiography
timeFrame: up to 24 months
measure: Change in VO2 Max
timeFrame: up to 24 months
measure: Changes in cardiac medications, including daily diuretic dose.
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM - Health Care Campus
Study officials:
References: