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Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

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ClinicalTrials.gov Identifier: NCT00621491
Recruitment Status : Completed
First Posted : February 22, 2008
Last Update Posted : October 26, 2012
Information provided by (Responsible Party):

Study Description
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 implantation in high-risk patients.

Condition or disease Intervention/treatment
Cardiac Pacing Complications Venous Thrombosis Drug: Warfarin

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 develop early, and their incidence decreases gradually within 6 months after device implantation. Ventricular dysfunction and previous transvenous temporary leads ipsilateral to the permanent implant are risk factors identified in a previous study performed at our institution and other risk factors have been reported recently.The usefulness of prophylactic therapeutic strategies to prevent these complications, however,remains unknown. This randomized trial examined the effects of warfarin in the prevention of these complications in high-risk patients. After device implantation, patients were randomly assigned to receive either placebo or warfarin. Periodical clinical and laboratorial evaluations were performed to anticoagulant management. Following the six-month period, every patient was submitted to a digital subtraction venography.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients
Study Start Date : February 2004
Primary Completion Date : September 2007
Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Single daily dose of Placebo during six months
Drug: Warfarin
Single daily dose of Warfarin (5 mg/orally), adjusted to achieve an International Normalized Ratio (INR) between 2 to 3.5 times the normal value during six months
Other Name: oral anticoagulants

Outcome Measures

Primary Outcome Measures :
  1. Incidence of venous obstructions observed by digital subtraction venography [ Time Frame: Six months ]

Secondary Outcome Measures :
  1. Safety of anticoagulant therapy, morbidity and overall mortality [ Time Frame: Six months ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621491

Heart Institute (InCor) - Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Sao Paulo, SP, Brazil, 05403-900
Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study Chair: Roberto Costa, MD PhD University of Sao Paulo
Principal Investigator: Katia R Silva, RN PhD University of Sao Paulo
More Information

Responsible Party: Roberto Costa, MD PhD, Associate Professor of Cardiovascular Surgery, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT00621491     History of Changes
Other Study ID Numbers: SDC 2273/03/067
First Posted: February 22, 2008    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: January 2008

Keywords provided by Roberto Costa, University of Sao Paulo:
cardiac pacing
pacing complication
venous thrombosis
randomized trial

Additional relevant MeSH terms:
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases