Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

Elimination of Ventricular Premature Beats With CaTheter Ablation Versus OPtImal Anti-arrhythmic Drug Treatment

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of ventricular premature beats (VPB) with catheter ablation versus optimal anti-arrhythmic drugs (AAD) treatment with flecainide/verapamil or sotalol.

The ECTOPIA trial is a randomized, multicenter, clinical trial to assess elimination of VPB with catheter ablation versus optimal AAD treatment with flecainide/verapamil or sotalol. Due to the use of different AAD (with and without beta-blocking abilities) the investigators will be able to explore the secondary objectives. Finally, this study will assess safety of ablation of non-RVOT VPBs and long-term treatment with two different AAD.

Inclusion Criteria:

• Patients willing and capable to provide written informed consent
• Patients with frequent symptomatic VPB and/or nonsustained VTs with burden ≥ 5% on 24 hour Holter monitor AND
• Absence of structural heart disease (excluded by echocardiogram) AND
• Absence of underlying cardiac ischemia (ruled out by treadmill test, CT coronary arteries, nuclear scintigraphy or coronary angiography) AND
• Patient is considered an acceptable candidate for catheter ablation treatment with a dominant morphology of VPB/VT origin judged by the treating physician.
• For those already undergoing treatment, all antiarrhythmic drugs including digitalis must be discontinued during a 2-week washout period before entry to the study

Exclusion Criteria:

• Age >75 years
• Previous catheter ablation therapy for VPB/VT
• Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)
• Wolff-parkinson-white (WPW) syndrome
• Use of medication with risk of QTc prolongation (e.g. antidepressant, antiemetic), except for study medication sotalol.
• Left ventricular dysfunction (LV ejection fraction <55%)
• Estimated glomerular filtration rate < 50 ml/min/1.73 m2
• Hepatic impairment defined by a total bilirubin ≥ 2 times the upper limit (ULN) of normal, or alanine aminotransferase (ALAT) or aspartate aminotransferase (ASAT) ≥ 3 times ULN at screening
• Untreated hypo- or hyperthyroidism or electrolyte imbalance
• Untreated obstructive sleep apnea
• Patients with history of myocardial infarction or bypass surgery
• More than grade 1/3 valvular regurgitation and/or significant valve stenosis (moderate or severe)
• Contraindication for any of the antiarrhythmic drugs used in this study
• Enrolment in another clinical study
• Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertile age
• Mental or physical inability to participate in the study
• Life expectancy ≤ 12 months