Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

• Status: Completed
• Trial end date: 2008-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study was to compare the safety and efficacy of warfarin versus placebo, administered for 6 months, in the prevention of thromboembolic complications after transvenous cardiac devices implantation in high-risk patients.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Sao Paulo
• Collaborators: Conselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de Amparo à Pesquisa do Estado de São Paulo
• Treatments: Anticoagulants; Warfarin

Criteria

Inclusion Criteria:

• adults patients submitted to first transvenous implant of pacemakers, implantable cardioverter-defibrillator, or cardiac resynchronization therapy devices

• left ventricular ejection fraction ≤0.40 and/or

• previous transvenous temporary leads ipsilateral to the permanent device implant

Exclusion Criteria:

• history of venous thromboembolism

• atrial fibrillation

• coagulopathy or platelet disorder

• malignancy

• gastro-intestinal hemorrhage or active gastro-duodenal ulcer in the past 6 months

• abnormal prothrombin time (PT)or an international normalized ratio (INR) >40%, or treated with oral anticoagulants