Trial | NCT03845010  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    22
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.
Study Started
Feb 12
2019
Primary Completion
Jan 17
2023
Study Completion
Jan 17
2023
Last Update
Jun 28
2023

Drug Sotalol

Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)

Drug Flecainide and verapamil [flecainide (tambocor), verapamil (calan)]

Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day

Procedure Catheter ablation

Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine

Sotalol Active Comparator

Flecainide and verapamil Active Comparator

Catheter ablation Active Comparator

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
No Results Posted