Aortic Stenosis, Non-rheumatic
Conditions
Keywords
balloon aortic valvuloplasty indication, heparin, hemorrhagic, ischemic
Brief summary
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.
Interventions
DRUGHeparin
Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure
DRUGNaCl
valvuloplasty is performed without heparin (placebo injection)
Sponsors
University Hospital, Montpellier
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be over 18 * carry a tight and symptomatic aortic stenosis * have an indication for a ballon aortic valvuloplasty * Subject have signed his written informed consent
Exclusion criteria
* Have an absence of femoral surgical approach * have a criticial hemodynamic state, considered as outdrove for the treatment * have a severe aortic failure * allergia to heparin * contraindication to heparin or/and local anaesthetic * be treted by low molecular weight heparin in less than 12 hoursbefore the intervention or by standard heparin in less than 4 hours before the valvulopasty * have a tight but not symptomatic aortic stenosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious complication : vascular, hemorrhagic or ischaemic complication | Up to10 days after the valvuloplasty (D1-D10 after the intervention) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication) | up to30 days after the valvuloplasty (until D30 after intervention) | Non serious complication is complication directly associated with the valvuloplasty which could be vascular complications medically treated (compression), BARC 2 hemorrhage, general procedure complications |
| number of a serious complication : vascular, hemorrhagic or ischaemic complication | up to 30 days after valvuloplasty | — |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFlorence Leclercq, PU PH
UH Montpellier
Outcome results
None listed