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Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
The Effect of Enoxaparin Sodium on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Scientific title
The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deep Vein Thrombosis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Blood 0 0 0 0
Clotting disorders

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Clexane

Active Comparator: clexane - patients received clexane

No Intervention: non clexane - no clexane given

Treatment: Drugs: Clexane

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Incidence of deep vein thrombosis
Timepoint [1] 0 0
1 year

Key inclusion criteria
- Patients undergoing EPS/RFA for the diagnosis and or treatment of SVT based on patient
history or ECG evidence.
Minimum age
18 Years
Maximum age
80 Years
Both males and females
Can healthy volunteers participate?
Key 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

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Melbourne hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3050 - Melbourne

Funding & Sponsors
Primary sponsor type
Melbourne Health
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Name [2] 0 0
National Heart Foundation, Australia
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Paul Sparks, MBBS, PhD. FRACP
Address 0 0
Melbourne Health
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see