The study purpose is to evaluate the safety and feasibility of the CORolla™ TAA in two treatment groups, "CORolla™ Stand-alone group" and " AVR \& CORolla™ Add on group".
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Spedali Civili - Brescia Hospital
Brescia, Italy
RECRUITINGMultimedica
Milan, Italy
NOT_YET_RECRUITINGCardiovasculare related SAEs
Investigational device safety with the intended study population with respect to 12 months follow up will be demonstrated using the following: Cardiovascular mortality and morbidity reports at 30 days post surgery. Serious adverse events: death, arrhythmia, CVA, AMI, bleeding and valve injury at 12 months post-surgery.
Time frame: 12 month post surgery
feasibility
Change in Quality of Life (QoL): Minnesota Living with Heart Failure.
Time frame: up to 36 month post surgery
Feasibility
Change in NYHA f. class
Time frame: up to 36 month post surgery
Feasibility
Change in exercise capacity as measured by the Six-Minute Walk test
Time frame: up to 36 month post surgery
Feasibility
Composite rate of HF death and re-hospitalization at 6 months and 1 year.
Time frame: Up to 36 month post surgery
Feasibility
Impact of CORolla™ TAA therapy on markers of diastolic dysfunction assessed by conventional echocardiography imaging (e.g LAVI index etc)and novel approach including Tissue Doppler Imaging (TDI)
Time frame: up to 36 month post surgery
Feasibility
Change of Wedge pressure - for safety assessment and impact of CORolla™ TAA therapy on this marker of diastolic dysfunction
Time frame: up to 36 month post surgery
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Feasibility
Changes in cardiac medical therapy including daily diuretic dose
Time frame: up to 36 month post surgery