Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Maatschap Cardiologie Zwolle
• Treatments: Anti-Arrhythmia Agents; Flecainide; Sotalol; Verapamil

Criteria

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