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

Aortic Stenosis, Non-rheumatic Clinical Trial

— HEPAVALV  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01823393
• Other study ID #: 9026
• Status: Terminated
• Phase: Phase 4
• Start date: January 24, 2013
• Est. completion date: October 22, 2016

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 94
• Est. completion date: October 22, 2016
• Est. primary completion date: October 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Stenosis, Non-rheumatic
• Aortic Valve Stenosis

Intervention

Drug:
• Heparin
Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure
• NaCl
valvuloplasty is performed without heparin (placebo injection)

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of serious complication : vascular, hemorrhagic or ischaemic complication		Up to10 days after the valvuloplasty (D1-D10 after the intervention)
Secondary	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)
Secondary	number of a serious complication : vascular, hemorrhagic or ischaemic complication		up to 30 days after valvuloplasty