162
Participants
Start Date
July 8, 2020
Primary Completion Date
June 30, 2026
Study Completion Date
June 30, 2026
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."
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)."
RECRUITING
Royal Prince Alfred Hospital, Camperdown
RECRUITING
Royal North Shore Hospital, Saint Leonards
RECRUITING
Westmead Hospital, Westmead
RECRUITING
Blacktown Hospital, Blacktown
RECRUITING
John Hunter Hospital, New Lambton Heights
NOT_YET_RECRUITING
The Canberra Hospital, Garran
RECRUITING
Nepean Hospital, Kingswood
RECRUITING
The Alfred Hospital, Melbourne
NOT_YET_RECRUITING
The Royal Melbourne Hospital, Parkville
RECRUITING
The Prince Charles Hospital, Chermside
RECRUITING
Gold Coast University Hospital, Southport
RECRUITING
Royal Adelaide Hospital, Adelaide
Western Sydney Local Health District
OTHER