Status:
COMPLETED
Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Cardiac Pacing
Complications
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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 ...
Detailed Description
Venous lesions following cardiac devices implantation are a common complication of transvenous access that may cause disease manifestations and difficulties during reoperations. These lesions tend to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2008
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT00621491
Start Date
February 1 2004
End Date
July 1 2008
Last Update
October 26 2012
Active Locations (1)
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1
Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
São Paulo, São Paulo, Brazil, 05403-900