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TERMINATED
NCT01823393
PHASE4

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

Sponsor: University Hospital, Montpellier

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

94

Start Date

2013-01-24

Completion Date

2016-10-22

Last Updated

2026-06-12

Healthy Volunteers

No

Interventions

DRUG

Heparin

Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure

DRUG

NaCl

valvuloplasty is performed without heparin (placebo injection)

Locations (1)

Montpellier University Hospital

Montpellier, France