Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure

• Status: Terminated
• Trial end date: 2016-10-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Calcium heparin; Heparin

Criteria

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