Elimination of ventricular premature beats and ventricular tachycardia with catheter ablation versus optimal anti-arrhythmic drug treatment

Phase 1

• Conditions: Premature ventricular beats, ventricular ectopy, ventricle tachycardia; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001518-13-NL
• Lead Sponsor: Maatschap Cardiologie Zwolle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

-Patients willing and capable to provide written informed consent
-Patients with frequent symptomatic VPB/VT and/or nonsustained VTs with a burden of = 5% on 24 hour Holter monitor AND
-Absence of structural heart disease AND
-Absence of underlying cardiac ischemia 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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

-Age >75 years
- Previous catheter ablation therapy for VPB/VT
-Patients with sustained ventricular tachycardia or cardiac channelopathies (e.g. CPVT, long- or short QT syndrome, Brugada syndrome)
-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 ALAT or 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)
- ontraindication 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified