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Catheter Ablation versus Medical Therapy for Ventricular Tachycardia: A Randomised Trial

Not Applicable
Recruiting
Conditions
Structural Heart Disease
Ventricular Tachycardia
Dilated Cardiomyopathy
Sarcoidosis
Hypertrophic Cardiomyopathy
Arrhythmogenic right ventricular cardiomyopathy
Ischemic cardiomyopathy
Cardiovascular - Other cardiovascular diseases
Registration Number
ACTRN12620000045910
Lead Sponsor
Western Sydney Local Health District
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
162
Inclusion Criteria

Patients will be eligible for inclusion if they have:
1.Greater than or equal to 1 prior episode of sustained VT in the prior 6 months;
a.Spontaneous VT: greater than or equal to 1 episode of monomorphic VT treated by anti-tachycardia pacing (ATP) and/or internal shock by an ICD; lasting greater than or equal to 30 seconds in the absence of intra-cardiac device therapy that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
b.Spontaneous VT: greater than or equal to 1 episode of sustained spontaneous monomorphic VT lasting greater than or equal to 30 seconds documented on holter, ECG, Loop recorder or other cardiac monitoring device that could either be self terminating or require reversion by pharmacological therapy or external cardioversion;
c.Inducible VT: with syncope or palpitations – inducible VT defined as sustained monomorphic VT of CL greater than or equal to 200ms lasting for greater than or equal to 10s during a cardiac electrophysiology study (note with 4 extrastimuli with or without provocation with isoprenaline);
2.Already a recipient of an implanted cardiac device such as a pacemaker, defibrillator or a cardiac resynchronisation therapy device and/or is indicated to receive one given a new diagnosis of structural heart disease, based on current guideline recommendations;
3.Aged greater than or equal to 18 years.

Exclusion Criteria

Patients will be excluded if they are:
1.Unable or unwilling to provide informed consent or patients physician feels there is not significant equipoise to justify randomisation;
2.Women who are pregnant, breast feeding;
3.Medical illness with an anticipated life expectancy < 3 months;
4.Unable to complete study procedures or unwilling to be followed up;
5.Have a concomitant illness, physical impairment or mental condition which in the opinion of the study team/ primary care physician could interfere with the conduct of the study including outcome assessments;
6.Known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergic polymorphic VT;
7.Known prior diagnosis of no structural heart disease, or idiopathic ventricular arrhythmia.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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