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

This study has been terminated.
(Difficulty of inclusion)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01823393
First Posted: April 4, 2013
Last Update Posted: December 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose
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.

Condition Intervention Phase
Aortic Stenosis, Non-rheumatic Drug: Heparin Drug: NaCl Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Balloon Aortic Valvuloplasty Performed Without Heparin to Decrease Vascular and Bleeding Complications of the Procedure

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

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

Secondary Outcome Measures:
  • 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

  • number of a serious complication : vascular, hemorrhagic or ischaemic complication [ Time Frame: up to 30 days after valvuloplasty ]

Enrollment: 94
Study Start Date: January 2013
Estimated Study Completion Date: March 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Unfractioned heparin
Placebo Comparator: NaCl
without heparin
Drug: NaCl
valvuloplasty is performed without heparin (placebo injection)
Other Name: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01823393


Locations
France
Montpellier University Hospital
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Florence Leclercq, PU PH UH Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01823393     History of Changes
Other Study ID Numbers: 9026
First Submitted: March 22, 2013
First Posted: April 4, 2013
Last Update Posted: December 1, 2016
Last Verified: November 2016

Keywords provided by University Hospital, Montpellier:
balloon aortic valvuloplasty indication
heparin
hemorrhagic
ischemic

Additional relevant MeSH terms:
Aortic Valve Stenosis
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Calcium heparin
Heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action