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

NCT01823393 | Terminated Phase 4

• 1 other identifier: 9026
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis, Non-rheumatic

Keywords

balloon aortic valvuloplasty indication; heparin; hemorrhagic; ischemic

Outcome Measures

Primary Outcomes (1)

• Number of serious complication : vascular, hemorrhagic or ischaemic complication

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

Secondary Outcomes (2)

• 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)

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

  up to 30 days after valvuloplasty

Study Arms (2)

Heparin

EXPERIMENTAL

injection of unfractionated heparin (50 IU / kg)

Drug: Heparin

NaCl

PLACEBO COMPARATOR

without heparin

Drug: NaCl

Interventions

Heparin DRUG

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

Also known as: Unfractioned heparin

Heparin

NaCl DRUG

valvuloplasty is performed without heparin (placebo injection)

Also known as: placebo

NaCl

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Ischemia

Interventions

Heparin

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Florence Leclercq, PU PH

  UH Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2013
• First Posted: April 4, 2013
• Study Start: January 24, 2013
• Primary Completion: October 22, 2016
• Study Completion: October 22, 2016
• Last Updated: October 21, 2021

Record last verified: 2021-10

Locations

FR (1)