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

University Hospital Center (CHU)

Status and phase: Terminated; Phase 4

Conditions: Aortic Stenosis, Non-rheumatic

Treatments: Drug: NaCl; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT01823393

9026 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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94 participants in 2 patient groups, including a placebo group

Heparin

Experimental group

Description:

injection of unfractionated heparin (50 IU / kg)

Treatment:

Drug: Heparin

NaCl

Placebo Comparator group

Description:

without heparin

Treatment:

Drug: NaCl