A prospective multi-center study in which patients with an acute heart attack (in the left anterior descending artery) with ECG changes (ST segment elevation) receive angioplasty followed by stent placement and 90 minutes of PICSO treatment. This is a proof of concept study designed to document the safety and feasibility of the Pressure Controlled Intermittent Coronary Sinus Occlusion (PICSO) Impulse system.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.
Academic Medical Center - University of Amsterdam
Amsterdam, Netherlands
Amphia Hospital
Breda, Netherlands
Successful delivery of PICSO treatment
Assessment of the feasibiity of PICSO in STEMI patients defined as the successful elivery of the PICSO catheter and the successful administration of PICSO treatment for 90 minutes
Time frame: 90 minutes
MRI measurement of infarct size
Infarct size assessed by cardiac MRI between 2-5 days post primary PCI and again at 120 days follow up
Time frame: 4 months
Assessment of left ventricular function
Left ventricular function assessed by echocardiography between 2-5 days after primary PCI and at 120 days
Time frame: 4 months
Assessment of microvascular perfusion
Microvascular perfusion assessed by cardiac MRI between 2-5 days after primary PCI and at 120 days
Time frame: 4 months
Resolution of ST-segment elevation
Occurrence of complete resolution of ST-segment elevation 30, 60, 90 and 120 minutes after last contrast injection prior to PICSO placement procedure on 24 hour continuous 12 lead ECG Holter monitor recording
Time frame: 24 hours
Measurement of ST segment time curve area
ST segment time curve area for the first 3 hours on 24 hour continuous 12 lead ECG Holter monitor recording.
Time frame: 3 hours
Number of adverse events
Safety endpoints recorded are Major Adverse Cardiac Events (MACE), Major Adverse Cardiac and Cerebrovascular Events (MACCE), net adverse clinical events (MACE and bleeding), Serious and non serious Adverse Device Events ((S)ADE) rates
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Time frame: 6 months