Ballon aortic valvuloplasty performed without heparin to decrease vascular and bleeding complications of the procedure

Ballon aortic valvuloplasty performed without heparin to decrease vascular and bleeding complications of the procedure - HEPAVALV

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003391-39-FR

Enrollment

130

Registered

2012-09-24

Start date

2012-10-26

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic stenosis MedDRA version: 14.1 Level: PT Classification code 10002906 Term: Aortic stenosis System Organ Class: 10047065 - Vascular disorders

Interventions

Trade Name: Heparin sodium CHOAY Product Name: Heparin sodium CHOAY Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of th

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must : - be over 18 and carry a tight and symptomatic aortic stenosis - have an indication for a balloon aortic valvuloplasty - be informed about the study and have given his written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 130 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Patients must not : - have an absence of femoral surgical approach - have a critical hemodynamic state, considered as outdrove for the treatment - have a severe aortic failure - be allergic to heparin - have a contraindication to the use of heparin - have a contraindication to local anaesthetic - be treated by low molecular weight heparin in less than 12 hours before the valvuloplasty or by standard heparin in less than 4 hours before the valvuloplasty - have a tight but not symptomatic aortic stenosis - be pregnant, breast-feeding, with no rights from the national health insurance programme

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 risk of ischaemic events.;Secondary Objective: To assess the whole complications of the procedure, including vascular complications.;Primary end point(s): - the occurrence of a serious complication, whether it is a vascular, hemorrhagic or ischaemic complication Are defined as serious : - the vascular complications that involve a surgery - the hemorrhagic complications that are equal or superior to the 3rd stage according to the BARC classification - the ischaemic complications that involve the occurrence of acute ischemia, mesenteric ischemia, ischaemic CVA, heart stroke or systemic embolism;Timepoint(s) of evaluation of this end point: At follow-up visits 2 and 3 (D1-D10 and D30 after the intervention)	—

Measure

Time frame

Main Objective: 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 risk of ischaemic events.;Secondary Objective: To assess the whole complications of the procedure, including vascular complications.;Primary end point(s): - the occurrence of a serious complication, whether it is a vascular, hemorrhagic or ischaemic complication Are defined as serious : - the vascular complications that involve a surgery - the hemorrhagic complications that are equal or superior to the 3rd stage according to the BARC classification - the ischaemic complications that involve the occurrence of acute ischemia, mesenteric ischemia, ischaemic CVA, heart stroke or systemic embolism;Timepoint(s) of evaluation of this end point: At follow-up visits 2 and 3 (D1-D10 and D30 after the intervention)

—

Secondary

Measure	Time frame
Secondary end point(s): - The occurence of any non-serious complications directly associated with the procedure - The occurrence of complications non associated to the procedure;Timepoint(s) of evaluation of this end point: At follow-up visits 2 and 3 (D1-D10 and D30 after the intervention)	—

Countries

France

Contacts

Public ContactDRI

Direction de la Recherche et de l'Innovation

c-chauveton@chu-montpellier.fr0033467330924

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026