Could ditching heparin during heart valve repair cut bleeding risks?
NCT ID NCT01823393
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests whether performing balloon aortic valvuloplasty without the blood thinner heparin reduces serious bleeding and blood vessel complications. About 94 adults with severe, symptomatic aortic stenosis will be randomly assigned to receive either heparin or a placebo during the procedure. The study aims to see if avoiding heparin lowers complications without increasing the risk of stroke or other ischemic events.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Heparin (unfractionated heparin) and placebo (NaCl)
- What this could lead to
- If skipping heparin works, it could make a common heart procedure safer by lowering bleeding and blood vessel damage risks.
- What could go wrong
- This is a small, single-center trial. Skipping heparin might increase the chance of blood clots or stroke during the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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94 people
The number who actually took part.
- Started
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Jan 2013
- Finished
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Oct 2016
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Montpellier University Hospital
Montpellier, 34295, France