Antikoagulanttihoito varfariinilla sydäntahdistimen asennuksen yhteydessä - Tahdistin-Varfariini

• Conditions: The study population will consist of patients admitted for an elective implantation of a pacemaker or an arrhythmia device. The underlying medical conditions warranting the implantation of the device in this population are various. Generally accepted guidelines for the clinical indications will be followed. The clinical indications for warfarin use in the study population are also various and generally accepted indications for anticoagulant treatment.

• Registration Number: EUCTR2005-000390-22-FI
• Lead Sponsor: Turku University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01-28
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Any patient scheduled for an elective implantation of pacemaker or arrhythmia device currently treated with warfarin, aspirin or neither.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Excessive intensity of anticoagulation as defined by International Normalized Ratio (INR) of more than 3.0
- Known bleeding disorder or hemorrhagic diathesis
- Known contraindication for pacemaker implantation
- Previously implanted mechanical heart valve prosthesis
- Any contraindication for interrupting warfarin treatment
- Significant anemia as defined by hemoglobin level of less than 100 g/L

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified