Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease
Condition: Heart Diseases; Cardiomyopathies; Ventricular Premature Complexes
MeSH terms: Premature Birth; Heart Diseases; Cardiomyopathies; Ventricular Premature Complexes
Study type: Interventional
Phase: Phase 3

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.
    

Detailed description: 
      Premature ventricular contractions (PVCs) are frequently encountered in patients with or
      without structural heart disease. Even though PVCs in healthy subjects are considered to be a
      benign arrhythmia. There is also evidence for the risk of a reversible cardiomyopathy due to
      the PVC-induced inter- and intraventricular dyssynchrony. Data show that elimination of PVCs
      by catheter ablation leads to an improvement of left ventricular dysfunction. In one-half of
      the heart failure patients frequent PVCs occur with more than 1000/24 h. In patients with
      structural heart disease premature ventricular contractions (PVCs) lead to an increased
      mortality risk with only a burden of 10 PVC per hour. Further decreasing of left ventricular
      function and worsening of heart failure are described. Therefore, therapy of frequent
      monomorphic PVCs is recommended in these subjects. Beta-blockers as part of standard therapy
      often remain ineffective or may lead to a paradoxic effect in patients with bradycardia. A
      limiting factor for selection of antiarrhythmic drug due to increasing mortality is the
      presence of structural heart disease. So in the most cases amiodarone is indicated. There are
      data showing improvement of LV function after suppression of PVCs by amiodarone with a
      significant reduction of the PVC burden in comparison to baseline. However, the adverse
      effects of amiodarone are well-known especially in long-term therapy. On the other hand,
      radiofrequency catheter ablation is a widely applied and safe treatment option for PVCs with
      a high acute success rate of up to 90% PVC reduction in various circumstances like
      pre-existing heart failure and post myocardial infarction subjects. Some small-sample studies
      show the benefit of catheter ablation in subjects with depressed LV function. To date, there
      are no randomized data for comparison of catheter ablation and amiodarone for therapy of PVCs
      in patients with structural heart disease.
    

Intervention name(s): Procedure (Radiofrequency catheter ablation); Amiodarone
Intervention type(s): Procedure; Drug
Intervention description(s): Radiofrequency catheter ablation; Amiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as:
Antiarrhythmic Drug Amiodarone
Intervention MeSH terms: Amiodarone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment