To assess if the non use of heparin sodium during balloon aortic valvuloplasty reduces serious complications due to the procedure, by decreasing the rate of vascular and hemorrhagic complications without increasing the rate of ischeamic events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
94
Montpellier University Hospital
Montpellier, France
Number of serious complication : vascular, hemorrhagic or ischaemic complication
Time frame: Up to10 days after the valvuloplasty (D1-D10 after the intervention)
Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)
Non serious complication is complication directly associated with the valvuloplasty which could be vascular complications medically treated (compression), BARC 2 hemorrhage, general procedure complications
Time frame: up to30 days after the valvuloplasty (until D30 after intervention)
number of a serious complication : vascular, hemorrhagic or ischaemic complication
Time frame: up to 30 days after valvuloplasty
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