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

Primary Purpose

Aortic Stenosis, Non-rheumatic

Status

Terminated

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Heparin

NaCl

About this trial

This is an interventional treatment trial for Aortic Stenosis, Non-rheumatic focused on measuring balloon aortic valvuloplasty indication, heparin, hemorrhagic, ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Montpellier University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Heparin

NaCl

Arm Description

injection of unfractionated heparin (50 IU / kg)

without heparin

Outcomes

Primary Outcome Measures

Number of serious complication : vascular, hemorrhagic or ischaemic complication

Secondary Outcome Measures

Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)

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

Full Information

NCT ID

NCT01823393

First Posted

March 22, 2013

Last Updated

October 20, 2021

Sponsor

University Hospital, Montpellier

1. Study Identification

Unique Protocol Identification Number

NCT01823393

Brief Title

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

Acronym

HEPAVALV

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Terminated

Why Stopped

Difficulty of inclusion

Study Start Date

January 24, 2013 (Actual)

Primary Completion Date

October 22, 2016 (Actual)

Study Completion Date

October 22, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Montpellier

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis, Non-rheumatic

Keywords

balloon aortic valvuloplasty indication, heparin, hemorrhagic, ischemic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Heparin

Arm Type

Experimental

Arm Description

injection of unfractionated heparin (50 IU / kg)

Arm Title

NaCl

Arm Type

Placebo Comparator

Arm Description

without heparin

Intervention Type

Drug

Intervention Name(s)

Heparin

Other Intervention Name(s)

Unfractioned heparin

Intervention Description

Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure

Intervention Type

Drug

Intervention Name(s)

NaCl

Other Intervention Name(s)

placebo

Intervention Description

valvuloplasty is performed without heparin (placebo injection)

Primary Outcome Measure Information:

Title

Number of serious complication : vascular, hemorrhagic or ischaemic complication

Time Frame

Up to10 days after the valvuloplasty (D1-D10 after the intervention)

Secondary Outcome Measure Information:

Title

Number of any non serious complication directly associated with the procedure (vascular, hemorrhagic or ischaemic complication)

Description

Time Frame

up to30 days after the valvuloplasty (until D30 after intervention)

Title

number of a serious complication : vascular, hemorrhagic or ischaemic complication

Time Frame

up to 30 days after valvuloplasty

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Florence Leclercq, PU PH

Organizational Affiliation

UH Montpellier

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montpellier University Hospital

City

Montpellier

ZIP/Postal Code

34295

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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