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

NCT ID: NCT01823393

Last Updated: 2021-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-24

Study Completion Date

2016-10-22

Brief Summary

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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

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Conditions

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Aortic Stenosis, Non-rheumatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Heparin

injection of unfractionated heparin (50 IU / kg)

Group Type EXPERIMENTAL

Heparin

Intervention Type DRUG

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

NaCl

without heparin

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

valvuloplasty is performed without heparin (placebo injection)

Interventions

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Heparin

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

Intervention Type DRUG

NaCl

valvuloplasty is performed without heparin (placebo injection)

Intervention Type DRUG

Other Intervention Names

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Unfractioned heparin placebo

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Florence Leclercq, PU PH

Role: PRINCIPAL_INVESTIGATOR

UH Montpellier

Locations

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Montpellier University Hospital

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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9026

Identifier Type: -

Identifier Source: org_study_id