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

Study Overview
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Brief Summary
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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.

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

Conditions
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Aortic Stenosis, Non-rheumatic

Intervention / Treatment
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* Drug: Heparin
* Drug: NaCl


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Heparin<br>injection of unfractionated heparin (50 IU / kg) | Drug: Heparin<br>* Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure<br>* Other names: Unfractioned heparin;|
| Placebo Comparator: NaCl<br>without heparin | Drug: NaCl<br>* valvuloplasty is performed without heparin (placebo injection)<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious complication : vascular, hemorrhagic or ischaemic complication |  | Up to10 days after the valvuloplasty (D1-D10 after the intervention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | up to30 days after the valvuloplasty (until D30 after intervention) | 
| number of a serious complication : vascular, hemorrhagic or ischaemic complication |  | up to 30 days after valvuloplasty | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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balloon aortic valvuloplasty indication, heparin, hemorrhagic, ischemic