A Multicenter, prospective, non-randomized, trial evaluating the safety and clinical efficacy of the next-generation, self-expandable Boston Scientific ACURATE NEO/TF Transcatheter Heart Valves, implanted in patients with severe aortic stenosis and the impact of predilatation in comparison with the Medtronic CoreValve EvolutT R/PRO systems from the DIRECT trial.
The aim of the present prospective, multicenter, non-randomized trial is to compare the device success rate and the in-hospital and 30-day safety and echocardiographic clinical outcomes between TAVI with and without predilatation in all comers undergoing implantation of self-expanding valves. Primary endpoint will be device success rate as defined by the VARC-2 criteria. Secondary endpoints involve the composite endpoint of early safety at 30 days, according to the VARC-2 definitions, specifically all cause mortality, cardiovascular mortality, stroke, acute kidney injury, life-threatening or disabling bleeding, major vascular complication, as well as the echocardiographic outcomes and valve performance as designated by the VARC-2 definitions at 30 days. VARC-1 and VARC-3 device success rates will be estimated as well. Study type: Observational Estimated Enrollment: 75 patients Allocation: Non - randomized, all comers Primary Purpose: Treatment Observational Model: Case-Control Condition or disease: Aortic valve stenosis Intervention/Treatment: Device: Boston Scientific ACURATE neoTM transfemoral TAVI system Time Perspective: Prospective Participating centers: Hippokration Hospital (Athens, Greece), Silesian Center for Heart Diseases (Zabrze, Poland), Athens Naval Hospital (Athens, Greece). It is possible that the number of the participating center may change. Methods: Patients treated with the Boston Scientific ACURATE NEO/TF system will be prospectively. All patients will be followed for at least 30 days.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Transcatheter implantation of the heart valve device ACURATE neo/TF in patients suffering from severe aortic stenosis and are candidates for this operation
Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation
Hippocration Hospital First Department of Cardiology, University of Athens, Medical School
Athens, Greece
Device success
ACURATE NEO/TF device implantation success rates, as designated by the VARC-2 criteria
Time frame: 30 days
All cause Mortality
Death teates during the hospitalization of the patient, as designated by the VARC-2 criteria
Time frame: 30 days
All stroke
Cerebrovascular accident rates during and after the hospitalization of the patient, as designated by the VARC-2 criteria
Time frame: 30 days
New pacemaker implantation
New pacemaker implantation rates during and after the hospitalization of the patient, as designated by the VARC-2 criteria
Time frame: 30 days
Major Vascular complications
Vascular complications rates during and after the hospitalization of the patient, as designated by the VARC-2 criteria
Time frame: 30 days
Echocardiographic endpoint
Echocardiographic endpoint (Post TAVI aortic valve area in cm2)
Time frame: 30 days
Post-dilatation
Post-dilatation rates
Time frame: 30 days
Major Bleeding
Major bleeding during and after the hospitalization of the patient, as designated by the VARC-2 criteria
Time frame: 30 days
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Acute kidney injury stage 2 or 3
AKI stage 2 or 3 during and after the hospitalization of the patient, as designated by the VARC-2 criteria
Time frame: 30 days
Device success
ACURATE NEO/TF device implantation success rates, as designated by the VARC-1 and VARC-3 criteria
Time frame: 30 days