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

10407

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.

2019-02-12

2023-01-17

2023-01-17

Completed

22

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized trial comparing catheter ablation with two different potent AADs with different engagement mechanisms in a 1:1:1 ratio with a crossover design in the AAD arm.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 22, 'type': 'ACTUAL'}}

2023-06-28