Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment (ECTOPIA)

Maatschap Cardiologie Zwolle

Status

Completed

Conditions

Ventricular Premature Beats

Treatments

Drug: Flecainide and verapamil

Procedure: Catheter ablation

Drug: Sotalol

Study type

Interventional

Funder types

Other

Identifiers

NCT03845010

10407

Details and patient eligibility

About

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.

Full description

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.

Enrollment

22 patients

Sex

All

Ages

76+ years old

Volunteers

No Healthy Volunteers

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