Trial information
A Study of Self Management and Self Testing in Patients With Heart Valve Replacement.
Status: Recruiting
Protocol number: TELEQIN 10/03
Company division: Diagnostic
Official Scientific Title: TELEQIN
Brief summary: This study will compare the effect of patient self-management, and patient self-testing plus telemetry, on the bleeding rate in patients with mechanical heart valve replacement. It will evaluate the telemedicine tool for patients who are not able to perform self-management.
Study type: Interventional; Randomized; Open Label; Active; Parallel study
Condition: Cardiovascular Abnormalities
Intervention type: Diagnostic Test
Intervention name: Set CoaguChek XS Systemasche
Inclusion criteria:
- adult patients, >=18 years of age;
- mechanical aortic, mitral or double valve replacement.
Exclusion criteria:
- chronic gastrointestinal ulceration;
- incompatibility to anticoagulants.
Gender: Males or Females
Age limits: Min: 18 Years Max: 99 Years
Accepts healthy volunteers: No
Anticipated start date: March, 2004
Trial registration date: 12/05/2006
Date last updated: 11/21/2008
Link to trial result
This trial is being conducted at the following locations:
Germany
- Bad Oeynhausen
- Bremen
- Dortmund
- Dresden
- Düsseldorf
- Essen
- Hamburg
- Lahr
- Ludwigshafen
- Marburg
- Oldenburg
- Regensburg
- Ulm