Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia

Last updated: August 29, 2022
Sponsor: Western Sydney Local Health District
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Chest Pain

Dysrhythmia

Treatment

N/A

Clinical Study ID

NCT05524077
CAAD-VT
  • Ages > 18
  • All Genders

Study Summary

Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important clinical sequela in patients with structural heart disease. VT generally occurs as a result of electrical re-entry in the presence of arrhythmogenic substrate (scar). Scar tissue forms due to an ischemic cardiomyopathy (ICM) from prior coronary obstructive disease or a non-ischemic cardiomyopathy (NICM) from an inflammatory or genetic disease.

AADs can reduce VT recurrence, but have significant limitations in treatment of VT. For example, amiodarone has high rates of side effects/toxicities and a finite effective usage before recurrence. ICDs prevent cardiac arrest and sudden death from VT, but do not stop VT occurring. Recurrent VT and ICD therapies decrease QOL, increase hospital visits, mortality, morbidity and risk of death. Improvement in techniques for mapping and ablation of VT have made CA an alternative.

Currently, there is limited evidence to guide clinicians either toward AAD therapy or CA in patients with NICM. This data shows significant benefit of CA over medical therapy in terms of VT free survival, survival free of VT storm and VT burden. Observational studies suggest that CA is effective in eliminating VT in NICM patients who have failed AADs, resulting in reduction of VT burden and AAD use over long term follow up. Furthermore, there is limited data on the efficacy of CA in early ICM with VT, or advanced ICM with VT. RCT data is almost exclusively on patients with modest ICM with VT, and this is not representative of the real-world scenario of patients with structural heart disease presenting with VT.

Therefore the primary objective is to determine in all patients with structural heart disease and spontaneous or inducible VT, if catheter ablation compared to standard medical therapy with anti-arrhythmic drugs results in a reduction of a composite endpoint of recurrent VT, VT storm and death at a median follow up of 18 months.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients will be eligible for inclusion if they have:

  1. ≥1 prior episode of sustained VT in the prior 6 months;
  2. Spontaneous VT: ≥1 episode of monomorphic VT treated by anti-tachycardia pacing (ATP) and/or internal shock by an ICD; lasting ≥30 seconds in the absence ofintra-cardiac device therapy that could either be self-terminating or requirereversion by pharmacological therapy or external cardioversion;
  3. Spontaneous VT: ≥1 episode of sustained spontaneous monomorphic VT lasting ≥30seconds documented on Holter, ECG, Loop recorder or other cardiac monitoringdevice that could either be self-terminating or require reversion bypharmacological therapy or external cardioversion;
  4. Inducible VT: with syncope or palpitations - inducible VT defined as sustainedmonomorphic VT of CL ≥200 ms lasting for ≥10 s during a cardiac electrophysiologystudy (note with 4 extrastimuli with or without provocation with isoprenaline);
  5. Already a recipient of an implanted cardiac device such as a pacemaker, defibrillatoror a cardiac resynchronisation therapy device and/or is indicated to receive one givena new diagnosis of structural heart disease, based on current guidelinerecommendations;
  6. Aged ≥18 years.

Exclusion

Exclusion Criteria: Patients will be excluded if they are:

  1. Unable or unwilling to provide informed consent or patients physician feels there isnot 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 theopinion of the study team/ primary care physician could interfere with the conduct ofthe study including outcome assessments;
  6. Known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergicpolymorphic VT;
  7. Known prior diagnosis of no structural heart disease, or idiopathic ventriculararrhythmia.

Study Design

Total Participants: 162
Study Start date:
July 08, 2020
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • The Canberra Hospital

    Garran, Australian Capital Territory 2605
    Australia

    Site Not Available

  • Blacktown Hospital

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales 2050
    Australia

    Active - Recruiting

  • Nepean Hospital

    Kingswood, New South Wales 2747
    Australia

    Active - Recruiting

  • John Hunter Hospital

    New Lambton Heights, New South Wales 2305
    Australia

    Active - Recruiting

  • Royal North Shore Hospital

    Saint Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • The Prince Charles Hospital

    Chermside, Queensland 4032
    Australia

    Active - Recruiting

  • Gold Coast University Hospital

    Southport, Queensland 4215
    Australia

    Active - Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • The Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Site Not Available

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