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

October 20, 2021 updated by: University Hospital, Montpellier
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heparin
injection of unfractionated heparin (50 IU / kg)
Drug: Heparin
Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure
Other Names:
  • Unfractioned heparin
Placebo Comparator: NaCl
without heparin
Drug: NaCl
valvuloplasty is performed without heparin (placebo injection)
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)
Time Frame: 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
up to30 days after the valvuloplasty (until D30 after intervention)
number of a serious complication : vascular, hemorrhagic or ischaemic complication
Time Frame: up to 30 days after valvuloplasty
up to 30 days after valvuloplasty

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Florence Leclercq, PU PH, UH Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2013

Primary Completion (Actual)

October 22, 2016

Study Completion (Actual)

October 22, 2016

Study Registration Dates

First Submitted

March 22, 2013

First Submitted That Met QC Criteria

March 29, 2013

First Posted (Estimate)

April 4, 2013

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 20, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9026 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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