Heart valve patients test home blood monitoring
NCT ID NCT00506870
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at whether people with mechanical heart valves can safely check their own blood thinning levels at home instead of going to a lab. Over 900 adults who recently had valve surgery used a device to measure their INR (a clotting test) and had monthly lab checks. The goal was to see if self-monitoring is medically safe and costs less than standard care.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INRatio or Coaguchek XS device for self-monitoring of INR
- What this could lead to
- If successful, this could show that self-monitoring is as safe and cheaper than regular lab visits for managing blood thinners after mechanical heart valve surgery.
- What could go wrong
- This trial is completed but results are not yet widely known. Self-monitoring requires training and may not suit all patients; errors in testing could lead to bleeding or clots.
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
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
919 people
The number who actually took part.
- Start date
-
Jun 2007
- Finished
-
Feb 2010
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * adults * patients fitted with one or more mechanical heart valves either alone or in combination with myocardial revascularization * oral anticoagulant treatment * patients with social security cover * written informed consent signed by both patient and investigator Exclusion Criteria: * women pregnant or liable to become pregnant during the study * nursing women * patients unable to master the self-monitoring procedures * individuals under judicial control or enquiry * patients consuming excessive amounts of alcohol ((\>40g/j for men et \>30g/j for women femmes ; 1 glass = 10g) * patients on dialysis * patients with incomplete understanding of instructions * blind patients and those unable to read * presence of circulating anticoagulant
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Mechanical prosthetic heart valve implantation are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Pôle Cardio-Thoracique - Hôpital Cardiologique du Haut-Lévêque - CHU de Bordeaux - Avenue de Magellan
Pessac, 33604, France