Catheter Ablation Versus Anti-arrhythmic Drugs for Ventricular Tachycardia

NARecruitingINTERVENTIONAL
Enrollment

162

Participants

Timeline

Start Date

July 8, 2020

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2026

Conditions
Heart Disease Structural DisorderVentricular TachycardiaCardiomyopathy, DilatedSarcoidosisCardiomyopathy, HypertrophicCardiomyopathy IschemicCardiomyopathy, FamilialArrhythmogenic Right Ventricular Cardiomyopathy 1Arrhythmogenic Left Ventricular Cardiomyopathy
Interventions
PROCEDURE

Ablation

"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."

DRUG

Anti-arrhythmic Drugs (AADs)

"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)."

Trial Locations (12)

2050

RECRUITING

Royal Prince Alfred Hospital, Camperdown

2065

RECRUITING

Royal North Shore Hospital, Saint Leonards

2145

RECRUITING

Westmead Hospital, Westmead

2148

RECRUITING

Blacktown Hospital, Blacktown

2305

RECRUITING

John Hunter Hospital, New Lambton Heights

2605

NOT_YET_RECRUITING

The Canberra Hospital, Garran

2747

RECRUITING

Nepean Hospital, Kingswood

3004

RECRUITING

The Alfred Hospital, Melbourne

3050

NOT_YET_RECRUITING

The Royal Melbourne Hospital, Parkville

4032

RECRUITING

The Prince Charles Hospital, Chermside

4215

RECRUITING

Gold Coast University Hospital, Southport

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

All Listed Sponsors
lead

Western Sydney Local Health District

OTHER