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Trial record 15 of 172 for:    "Heart Disease" | "Heparin"

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

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ClinicalTrials.gov Identifier: NCT01823393
Recruitment Status : Terminated (Difficulty of inclusion)
First Posted : April 4, 2013
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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.

Condition or disease Intervention/treatment Phase
Aortic Stenosis, Non-rheumatic Drug: Heparin Drug: NaCl Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 94 participants
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
Actual Study Start Date : January 24, 2013
Actual Primary Completion Date : October 22, 2016
Actual Study Completion Date : October 22, 2016


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 Name: Unfractioned heparin

Placebo Comparator: NaCl
without heparin
Drug: NaCl
valvuloplasty is performed without heparin (placebo injection)
Other Name: placebo




Primary Outcome Measures :
  1. 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 :
  1. 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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01823393     History of Changes
Other Study ID Numbers: 9026
First Posted: April 4, 2013    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Keywords provided by University Hospital, Montpellier:
balloon aortic valvuloplasty indication
heparin
hemorrhagic
ischemic
Additional relevant MeSH terms:
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Heart Diseases
Heparin
Calcium heparin
Aortic Valve Stenosis
Heart Valve Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action