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

Phase 4

Terminated

• Conditions: Aortic Stenosis, Non-rheumatic
• Interventions: Drug: NaCl; Drug: Heparin

• Registration Number: NCT01823393
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-24
• Study First Submitted: 2013-03-22
• Study First Submitted QC: 2013-03-29
• Study First Posted: 2013-04-04
• Primary Completion: 2016-10-22
• Study Completion: 2016-10-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-20
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NaCl	NaCl	without heparin
Heparin	Heparin	injection of unfractionated heparin (50 IU / kg)

Primary Outcome Measures

Name	Time	Method
Number of serious complication : vascular, hemorrhagic or ischaemic complication	Up to10 days after the valvuloplasty (D1-D10 after the intervention)

Secondary Outcome Measures

Name	Time	Method
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)	Non serious complication is complication directly associated with the valvuloplasty which could be vascular complications medically treated (compression), BARC 2 hemorrhage, general procedure complications

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France