Status:
TERMINATED
Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Aortic Stenosis, Non-rheumatic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 with...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2016
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT01823393
Start Date
January 24 2013
End Date
October 22 2016
Last Update
October 21 2021
Active Locations (1)
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1
Montpellier University Hospital
Montpellier, France, 34295