Prevention of Venous Thrombosis After Permanent Transvenous Leads Implantation

Randomized Controlled Clinical Trial for Prevention of Thromboembolic Complications After Permanent Transvenous Leads Implantation in High-risk Patients

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00621491

Enrollment

101

Registered

2008-02-22

Start date

2004-02-29

Completion date

2008-07-31

Last updated

2012-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Pacing, Complications, Venous Thrombosis

Keywords

cardiac pacing, pacing complication, venous thrombosis, warfarin, anticoagulation, randomized trial

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.

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.

Interventions

DRUGWarfarin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Incidence of venous obstructions observed by digital subtraction venography	Six months

Secondary

Measure	Time frame
Safety of anticoagulant therapy, morbidity and overall mortality	Six months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026