Comparing catheter ablation and anti-arrhythmic drugs for treating ventricular tachycardia

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

This study is testing whether catheter ablation works better than anti-arrhythmic drugs for people with recurrent ventricular tachycardia caused by heart problems.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Western Sydney Local Health District (other)
• Locations: 12 sites (Garran, Australian Capital Territory and 11 other locations)
• Trial ID: NCT05524077 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of catheter ablation compared to anti-arrhythmic drugs (AADs) in patients with recurrent ventricular tachycardia (VT) due to structural heart disease. The study aims to determine which treatment option better reduces the recurrence of VT and improves patient quality of life. Patients eligible for the trial must have experienced at least one episode of sustained VT in the past six months. The trial will be conducted at multiple hospitals in Australia, focusing on patients with specific heart conditions.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who have experienced at least one episode of sustained ventricular tachycardia in the past six months.

Not a fit: Patients who do not have a history of sustained ventricular tachycardia or those who are not candidates for catheter ablation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from recurrent ventricular tachycardia, potentially improving their quality of life and reducing hospital visits.

How similar studies have performed: Other studies have shown promising results with catheter ablation for ventricular tachycardia, suggesting that this approach may be effective, though this specific comparison with AADs is less established.

Eligibility criteria

Inclusion Criteria:

Patients will be eligible for inclusion if they have:

1. ≥1 prior episode of sustained VT in the prior 6 months;

   1. 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;
   2. 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;
   3. 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);
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 ≥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.

Where this trial is running

Garran, Australian Capital Territory and 11 other locations

• The Canberra Hospital — Garran, Australian Capital Territory, Australia (NOT_YET_RECRUITING)
• Blacktown Hospital — Blacktown, New South Wales, Australia (RECRUITING)
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia (RECRUITING)
• Nepean Hospital — Kingswood, New South Wales, Australia (RECRUITING)
• John Hunter Hospital — New Lambton Heights, New South Wales, Australia (RECRUITING)
• Royal North Shore Hospital — Saint Leonards, New South Wales, Australia (RECRUITING)
• Westmead Hospital — Westmead, New South Wales, Australia (RECRUITING)
• The Prince Charles Hospital — Chermside, Queensland, Australia (RECRUITING)
• Gold Coast University Hospital — Southport, Queensland, Australia (RECRUITING)
• Royal Adelaide Hospital — Adelaide, South Australia, Australia (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
• The Royal Melbourne Hospital — Parkville, Victoria, Australia (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Saurabh Kumar, MBBS, PhD — Western Sydney Local Health District
• Study coordinator: Saurabh Kumar, MBBS, PhD

Conditions: Heart Disease Structural Disorder, Ventricular Tachycardia, Cardiomyopathy, Dilated, Sarcoidosis, Cardiomyopathy, Hypertrophic, Cardiomyopathy Ischemic, Cardiomyopathy, Familial, Arrhythmogenic Right Ventricular Cardiomyopathy 1