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Difficulty of inclusion
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Heparin | Experimental | injection of unfractionated heparin (50 IU / kg) |
|
| NaCl | Placebo Comparator | without heparin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heparin | Drug | Valvuloplasty is performed in a conventional manner, ie with an injection of unfractionated heparin (50 IU / kg) at the start of procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious complication : vascular, hemorrhagic or ischaemic complication | Up to10 days after the valvuloplasty (D1-D10 after the intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to30 days after the valvuloplasty (until D30 after intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Leclercq, PU PH | UH Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montpellier University Hospital | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35402691 | Result | Akodad M, Labour J, Nogue E, Delseny D, Macia JC, Gervasoni R, Lattuca B, Nagot N, Roubille F, Cayla G, Leclercq F. Vascular complications and bleeding after balloon aortic valvuloplasty performed with or without heparin: HEPAVALVE randomized study. Int J Cardiol Heart Vasc. 2022 Jan 18;39:100951. doi: 10.1016/j.ijcha.2021.100951. eCollection 2022 Apr. |
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| ID | Term |
|---|---|
| D001024 | Aortic Valve Stenosis |
| D007511 | Ischemia |
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| NaCl | Drug | valvuloplasty is performed without heparin (placebo injection) |
|
|
| number of a serious complication : vascular, hemorrhagic or ischaemic complication | up to 30 days after valvuloplasty |
| D014694 |
| Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |