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

NCT01823393 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2021-10-21

No results posted yet for this study

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.

Conditions

  • Aortic Stenosis, Non-rheumatic

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)

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Florence Leclercq, PU PH · UH Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-24
Primary Completion
2016-10-22
Completion
2016-10-22

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01823393 on ClinicalTrials.gov