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Completed

NCT Number: NCT02924285

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

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.

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Key information

Age range

18 year–87 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Heart Center Leipzig

Leipzig, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Procedure (Radiofrequency catheter ablation)

Procedure

Radiofrequency catheter ablation

Amiodarone

Drug

Amiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as:

Antiarrhythmic Drug Amiodarone

Primary outcomes

  1. Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease

    Time frame: Baseline and after 6 weeks

    difference of the PVC burden in a 24 h Holter registration after 6 weeks and at baseline expressed as the amount of the baseline value ΔVES_r = (VES_6 - VES_0) / VES_0

Secondary outcomes

  1. Change in quality of life (QoL) score according EQ-5D questionnaire

    Time frame: Baseline, after 6 weeks and 12 months

  2. Change in 6 minute walking distance

    Time frame: Baseline, after 6 weeks and 12 months

  3. Change in left ventricular ejection fraction (LVEF)

    Time frame: Baseline, after 6 weeks and 12 months

  4. Change in serum NT-proBNP level

    Time frame: Baseline, after 6 weeks and 12 months

  5. Change in New York Heart Association (NYHA) functional class

    Time frame: Baseline, after 6 weeks and 12 months

  6. Occurrence of cardiovascular related hospitalization

    Time frame: after 6 weeks and 12 months

  7. Occurrence of drug adverse effects

    Time frame: after 6 weeks and 12 months

  8. Occurrence of procedure related complications

    Time frame: after 6 weeks and 12 months

  9. Difference of the PVC burden in a 24 h Holter registration after 12 months and at baseline expressed as the amount of the baseline value

    Time frame: Baseline and after 12 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Collaborators

  • Abbott Medical Devices
  • Helios Health Institute GmbH
  • Zentrum für Klinische Studien Leipzig

Registry information

Official study title

CAT-PVC Trial Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease: a Randomized Trial

Acronym: CAT-PVC

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Oct 5, 2016
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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