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

Completed

• Conditions: Premature ventricular beats; ventricular extrasystole; 10007521

• Registration Number: NL-OMON48860
• Lead Sponsor: Maatschap Cardiologie Zwolle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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% 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

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)
- Contraindication for any of the antiarrhythmic drugs used in this study
- Enrolment in another trial
- 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
• Study Design: Not specified