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NCT Number: NCT05524077

Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Heart Disease Structural Disorder Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Arrhythmias, Cardiac Arrhythmogenic Left Ventricular Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy 1 Arrhythmogenic Right Ventricular Dysplasia, Familial, 1 Cardiac Conduction System Disease Cardiomegaly Cardiomyopathies Cardiomyopathy Ischemic Cardiomyopathy, Dilated Cardiomyopathy, Familial Cardiomyopathy, Hypertrophic Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Valve Diseases Hemic and Lymphatic Diseases Hypersensitivity Hypersensitivity, Delayed Immune System Diseases Laminopathies Lymphatic Diseases Lymphoproliferative Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Sarcoidosis Tachycardia Tachycardia, Ventricular Ventricular Tachycardia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients will be eligible for inclusion if they have:

  • ≥1 prior episode of sustained VT in the prior 6 months;
  • 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 of intra-cardiac device therapy that could either be self-terminating or require reversion by pharmacological therapy or external cardioversion;
  • Spontaneous VT: ≥1 episode of sustained spontaneous monomorphic VT lasting ≥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;
  • Inducible VT: with syncope or palpitations - inducible VT defined as sustained monomorphic VT of CL ≥200 ms lasting for ≥10 s during a cardiac electrophysiology study (note with 4 extrastimuli with or without provocation with isoprenaline);
  • 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;
  • Aged ≥18 years.

Exclusion criteria

Patients will be excluded if they are:

  • Unable or unwilling to provide informed consent or patients physician feels there is not significant equipoise to justify randomisation;
  • Women who are pregnant, breast feeding;
  • Medical illness with an anticipated life expectancy <3 months;
  • Unable to complete study procedures or unwilling to be followed up;
  • 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;
  • Known channelopathy such as long QT, short QT, Brugada syndrome, catecholaminergic polymorphic VT;
  • Known prior diagnosis of no structural heart disease, or idiopathic ventricular arrhythmia.

Treatment and study plan

Ablation

Procedure

Catheter ablation (CA) will be performed in the standard fashion (described in international guidelines for the Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death from the AHA/ACC/HRS and the expert consensus statement on Catheter Ablation of Ventricular Arrhythmias from HRS/EHRA/APHRS/LAHRS). CA will be performed under conscious sedation or GA by an Electrophysiologist trained in cardiac arrhythmia ablation. CA will be guided by a combination of mapping techniques (standard practice), and described in guidelines for CA for VT. Mapping techniques will include pace, entrainment, activation, and electro-anatomic substrate mapping, where haemodynamically tolerated. Expected procedure duration is 3-6hrs.

Post-CA, AAD is stopped if patient was drug naïve pre-randomisation. The baseline type/dose of AAD pre-randomisation is continued if the patient was on an AAD pre-randomisation. Repeat ablations are permitted within 30-days post-randomisation.

Anti-arrhythmic Drugs (AADs)

Drug

Standard care usually encompasses patients who have not previously had AADs, being commenced on sotalol 80mg twice/day. Lower doses may be initiated by treating doctor, as clinically indicated. If there is contraindication to sotalol, another beta-blocker may be initiated using standard doses. Clinicians may consider alternative AADs if there is contraindication to beta-blockers. Doses would be up titrated to the maximal tolerated amount.

For patients already on an AAD, amiodarone would usually be added, as per VANISH trial.

They will receive a loading dose 400mg twice/day for 2 weeks, followed by 400mg/day for 4 weeks and 200mg/day thereafter. Patients who have "failed" amiodarone dose <300mg/day will receive a repeat loading dose of 400mg twice/day for 2 weeks, followed by 400mg/day for 1 week, and 300mg/day thereafter.

If the treating doctor decides to do a CA for VT, the occurrence and timepoint of cross-over will be recorded. Cross-over is estimated to be <2% (VANISH trial).

Primary outcomes

  1. Composite of Recurrent VT or VT storm

    Time frame: Primary outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. VT/VT Storm events after the 30-day treatment 'blanking' period after treatment initiation will be included.

    VT (detected by cardiac device as lasting ≥30 seconds or shorter in duration if treated by the ICD).

    VT storm (three or more documented episodes of VT within 24 hours or incessant VT).

  2. Death

    Time frame: Primary outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Death events at any time after randomisation will be included.

    Death (at any time) due to any cause.

Secondary outcomes

  1. Recurrent sustained VT

    Time frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. VT events will be included after the 30-day treatment 'blanking' period after treatment initiation.

    Recurrent sustained VT detected by implanted cardioverter defibrillator (ICD) (VT identified and treated by the ICD with anti-tachycardia pacing (ATP) and/or internal ICD delivered shock or ≥30 seconds of VT if untreated by ICD)

  2. VT storm

    Time frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. VT storm events will be included after the 30-day treatment 'blanking' period after treatment initiation.

    Three or more documented episodes of VT within 24 hours or incessant VT

  3. VT burden

    Time frame: 6 months after randomisation, with a 30-day treatment 'blanking' period after treatment initiation; and 6 months before randomisation

    VT burden (number of episodes of VT in the preceding 6 months compared to the 6 months after randomisation and therapy)

  4. Cardiovascular hospitalisation

    Time frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Events will be included after the 30-day treatment 'blanking' period after treatment initiation.

    All cardiovascular hospitalisation; heart failure; hospitalisation for arrhythmia

  5. Mortality

    Time frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Events will be included at any time after randomisation.

    All-cause mortality; cardiovascular mortality; non-cardiac death

  6. Effect of intervention on ventricular function

    Time frame: Outcome will be assessed at 3-, 6-, 12-, 18-, 24-, 30-, 36- months post-randomisation. Events will be included after the 30-day treatment 'blanking' period after treatment initiation.

    Effect of intervention on ventricular function as assessed by transthoracic echocardiography from baseline to 6-, 12-, 24- and 36-months' post intervention

Sponsors and collaborators

Lead sponsor

Western Sydney Local Health District

Other

Registry information

Official study title

Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia (CAAD-VT): A Randomised Trial

Acronym: CAAD-VT

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 1, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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