Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease

• Status: Completed
• Trial end date: 2021-03-04
• Target enrollment: 0
• Participant gender: All

Summary

For therapy of symptomatic premature ventricular complexes (PVCs) in subjects with structural heart disease the current European Guidelines for the management of patients with ventricular arrhythmias and the prevention of second cardiac death recommend catheter ablation as well as amiodarone with a class IIa indication. Due to the lack of randomized data this study investigates the comparison of catheter ablation and amiodarone for PVC treatment in patients with structural heart disease. Therefore, patients will be randomized to one of two treatment strategies: 1) catheter ablation, or 2) amiodarone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Heartcenter Leipzig GmbH; University of Leipzig
• Collaborators: Abbott Medical Devices; Leipzig Heart Institute GmbH; Zentrum für Klinische Studien Leipzig
• Treatments: Amiodarone; Anti-Arrhythmia Agents; Flecainide; Propafenone

Criteria

Inclusion Criteria:

• Structural heart disease with or without left ventricular dysfunction with

• PVCs on Holter monitoring (burden >10.000/d) AND/OR

• PVCs on Holter monitoring correlating with symptoms AND/OR

• Reduction of biventricular pacing <92% in subjects with implanted cardiac resynchronization therapy (CRT) device

• Age: 18-87 years

• Willing and capable of giving informed consent

Exclusion Criteria:

• Previous ablation procedure or amiodarone for PVC without success

• New York Heart Association (NYHA) functional class IV

• Intracardial thrombus

• Pulmonary fibrosis

• Liver cirrhosis ≥ CHILD B

• Manifest hyper- or hypothyreoidism

• Long QT (QTc > 500 ms if QRS<120 ms, if QRS>120 ms according to QTRR, QRS formula)

• Sick sinus syndrome with symptomatic bradycardia <55 bpm or AV node conduction delay without implanted pacing device

• Known side effects under amiodarone or iodine

• Idiopathic angioedema

• Comedication with known risk for torsade-de-pointes tachycardia

• Pregnancy or lactation