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

University Hospital, Montpellier1 site in 1 country94 target enrollmentJanuary 24, 2013

ConditionsAortic Stenosis, Non-rheumatic

InterventionsHeparin NaCl

DrugsHeparin NaCl

Overview

Phase: Phase 4
Intervention: Heparin
Conditions: Aortic Stenosis, Non-rheumatic
Sponsor: University Hospital, Montpellier
Enrollment: 94
Locations: 1
Primary Endpoint: Number of serious complication : vascular, hemorrhagic or ischaemic complication
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 24, 2013

End Date

October 22, 2016

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Heparin

injection of unfractionated heparin (50 IU / kg)

Intervention: Heparin

NaCl

without heparin

Intervention: NaCl

Outcomes

Primary Outcomes

Number of serious complication : vascular, hemorrhagic or ischaemic complication

Time Frame: Up to10 days after the valvuloplasty (D1-D10 after the intervention)

Secondary Outcomes

number of a serious complication : vascular, hemorrhagic or ischaemic complication(up to 30 days after valvuloplasty)
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))