Status:
COMPLETED
Elimination of VPB With Ablation Versus Anti-arrhythmic Drug Treatment
Lead Sponsor:
Maatschap Cardiologie Zwolle
Conditions:
Ventricular Premature Beats
Eligibility:
All Genders
76+ years
Phase:
NA
Brief 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 wi...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2023
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03845010
Start Date
February 12 2019
End Date
January 17 2023
Last Update
June 28 2023
Active Locations (1)
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1
Isala hospital
Zwolle, Netherlands