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The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00232271
Enrollment
35
Registered
2005-10-04
Start date
2005-08-31
Completion date
2011-02-28
Last updated
2013-05-30

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

Conditions

Deep Vein Thrombosis

Brief summary

The purpose of this study is to assess the effect of the anticoagulant(blood thinner) Clexane on the development of leg clots following electrophysiology studies (EPS) and or radiofrequency ablation (RFA). People who suffer heart palpitations will sometimes need hospital admission to undergo an electrophysiology study ( and or a Radiofrequency Ablation)in order to diagnose and or treat their condition. Radiofrequency ablation is a procedure to stop abnormal heart rhythms. EPS/RFA studies require the puncture of the leg veins . Previous experience has shown that following the puncture of leg veins there is a small risk of developing a blood clot in the leg. It is not known whether giving blood thinners (anticoagulants) after the procedure will decrease this risk Enoxaparin Sodium (Clexane) is an anticoagulant used extensively and safely following bone (Orthopaedic) surgery to prevent blood clots from developing in the legs

Interventions

Sponsors

Sanofi
CollaboratorINDUSTRY
National Heart Foundation, Australia
CollaboratorOTHER
Melbourne Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient history or ECG evidence.

Exclusion criteria

* Patients with a past history of DVT or PE. * Patients with a history of clotting disorders * Patients with active malignancies * Patients requiring full heparinisation during and after the procedure. * Chronic atrial flutter and atrial fibrillation ablation

Design outcomes

Primary

MeasureTime frame
Incidence of deep vein thrombosis1 year

Countries

Australia

Outcome results

None listed

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