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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
RAMBAM - Health Care Campus
Haifa, Israel
RECRUITINGNumber of participants with All-cause mortality and Serious Adverse Events (SAEAs)
Investigational device safety with the intended study population with respect to 6 months follow up will be demonstrated using the following: All-cause mortality and Serious Adverse Events (SAEAs) throughout 6 months post-surgery.
Time frame: 6 months
Incidence of in-hospital procedure success.
Success of the implant surgical procedure and ability to position the CORolla® TAA will be determined according to Implantation Rating Questionnaire.
Time frame: up ot 24 hour.
Rate of HF death and re-hospitalization due to HF (including IV diuretic)
Time frame: 6 months
Rate of HF death and re-hospitalization due to HF (including IV diuretic)
Time frame: 12 months
Rate, type and severity of procedure related and device-related events
Time frame: 30 days
Rate of device related Major Adverse Cardiac and Neurological Events (MACNE)
Time frame: up to 6 months
Change in Quality of Life (QoL) Questionnaire
Minnesota Living with Heart Failure.
Time frame: up to 24 months
Change in New York Heart Association functional Class (NYHA f. Cl).
Time frame: up to 24 months
Change in exercise capacity as measured by the Six-Minute Walk test.
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Time frame: up to 24 months
Device impact on diastolic dysfunction markers assessed by conventional echocardiography imaging and novel approach including Tissue Doppler Imaging (TDI).
Composite measure: Left atrial volume index \[ml/m\^2\], Early mitral flow velocity E \[ml/sec\], Mitral flow velocity during atrial systole A \[ml/sec\], E/A ratio, Mitral annular velocity e' \[mm/sec\], Declaration time \[msec\], E/e' \[ml/mm\], Left ventricular mass \[gr\], Ejection fiction \[%\], Pulmonary venous flow \[m/sec\], Transmitral flow propagation velocity \[cm/sec\].
Time frame: up to 24 months
Change of Wedge pressure
For safety assessment and impact of CORolla ® TAA therapy on this marker of diastolic dysfunction.
Time frame: up to 24 months
Change in Pulmonary Capillary Wedge Pressure during handgrip/ergometry
Applicable only to patients who are in a clinical condition that enables them to have the test and at sites that have the experience and the capabilities to perform this test.
Time frame: up to 24 months
Change in exercise testing during echocardiography
Composite measure: Maximal exercise tolerance defined as the number of metabolic equivalent (METs) at baseline and maximal: Early mitral flow velocity E \[ml/sec\], Mitral annular velocity e' \[mm/sec\] and E/e' \[ml/mm\]. Applicable only to patients who are in a clinical condition that enables them to have the test and at sites that have the experience to perform this test.
Time frame: up to 24 months
Change in VO2 Max
Applicable only to patients who are in a clinical condition that enables them to have the test and at sites that have the experience and the capabilities to perform this test.
Time frame: up to 24 months
Changes in cardiac medications, including daily diuretic dose.
The dose of furosemide \[mg/d\] and thiazide \[mg/d\] before and after the procedure and during follow up will be recorded and compared.
Time frame: up to 24 months