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

This study is currently recruiting participants.

Verified by Melbourne Health, October 2005

Sponsors and Collaborators:	Melbourne Health Sanofi-Aventis National Heart Foundation
Information provided by:	Melbourne Health
ClinicalTrials.gov Identifier:	NCT00232271

Purpose

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

Condition	Intervention
Deep Vein Thrombosis	Drug: Clexane

MedlinePlus related topics: Blood Thinners Deep Vein Thrombosis

Drug Information available for: Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Parallel Assignment
Official Title:	The Effect of Enoxaparin Sodium (Clexane) on the Incidence of Deep Vein Thrombosis Following Electrophysiology Studies and Radiofrequency Ablation.

Further study details as provided by Melbourne Health:

Estimated Enrollment:	200
Study Start Date:	August 2005

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232271

Contacts

Contact: Paul Sparks, MBBS,PhD, FRACP

0393427000 ext 27133

paul.sparks@mh.org.au

Locations

Australia, Victoria
Royal Melbourne hospital	Recruiting
Melbourne, Victoria, Australia, 3050
Contact: Paul Sparks, MBBS,PhD,FRACP 93427000 ext 27133 paul.sparks@mh.org.au
Contact: Fiona Sutherland 93427000 ext 27133 fiona.sutherland@mh.org.au
Principal Investigator: Paul Sparks, MBBS, PhD, FRACP

Sponsors and Collaborators

Melbourne Health

Sanofi-Aventis

National Heart Foundation

Investigators

Principal Investigator:

Paul Sparks, MBBS, PhD. FRACP

Melbourne Health

More Information

Study ID Numbers:	2004-157
Study First Received:	October 2, 2005
Last Updated:	July 31, 2006
ClinicalTrials.gov Identifier:	NCT00232271
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Study placed in the following topic categories:

Embolism and Thrombosis
Embolism
Vascular Diseases

Venous Thrombosis
Thrombosis
Enoxaparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009