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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01823393
First received: March 22, 2013
Last updated: March 29, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823393

Locations
France
Montpellier University Hospital Recruiting
Montpellier, France, 34295
Contact: claire chauveton    0467330924    c-chauveton@chu-montpellier.fr   
Principal Investigator: Florence Leclercq, Professor         
Sub-Investigator: Delphine Delseny, Interne         
Sub-Investigator: Jean Christophe Macia, PU PH         
Sub-Investigator: Richard Gervasoni, PH         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Florence Leclercq, PU PH UH Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01823393     History of Changes
Other Study ID Numbers: 9026
Study First Received: March 22, 2013
Last Updated: March 29, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on September 22, 2014