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

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Terminated

CT.gov ID

NCT01823393

Collaborator

(none)

Enrollment

Location

Arms

44.9

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

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 :

Jan 24, 2013

Actual Primary Completion Date :

Oct 22, 2016

Actual Study Completion Date :

Oct 22, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Number of serious complication : vascular, hemorrhagic or ischaemic complication [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) [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 [up to 30 days after valvuloplasty]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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