Trial Information

Summary: A Study of Self Management and Self Testing in Patients With Heart Valve Replacement.

Status: Recruiting

Protocol Number: TELEQIN 10/03

Sponsor:

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 Phase: N/A

Study Design / Study Details:

  • Purpose:
  • Allocation: Randomized
  • Masking: Open Label
  • Control: Active
  • Assignment: Parallel
  • Endpoints:

Study Type:

Interventional

Condition: Cardiovascular Abnormalities

Intervention Type: Diagnostic Test

Intervention Name: Set CoaguChek XS Systemasche

Primary Outcome:

Key Secondary Outcomes:

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: 12/14/2006

Link To Trial Results

Contact:

Research Site:
Located In:
Lahr, Germany, 77933
Telephone: 973-235-5000 or 800-526-6367

 

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Trial listings updated: August 20, 2008 at 2:20:52 PM


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