Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease (CAT-PVC)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiomyopathies; Ventricular Premature Complexes
• Intervention / Treatment: Procedure: Procedure (Radiofrequency catheter ablation); Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 3

Contacts and Locations

Study Locations

• Germany
  • Leipzig, Germany
    • Heart Center Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 87 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Procedure; Radiofrequency catheter ablation	Procedure: Procedure (Radiofrequency catheter ablation); Radiofrequency catheter ablation
Active Comparator: Antiarrhythmic Drug; Amiodarone	Drug: Amiodarone; Amiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as: Antiarrhythmic Drug Amiodarone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease	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	Baseline and after 6 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in quality of life (QoL) score according EQ-5D questionnaire	Baseline, after 6 weeks and 12 months
Change in 6 minute walking distance	Baseline, after 6 weeks and 12 months
Change in left ventricular ejection fraction (LVEF)	Baseline, after 6 weeks and 12 months
Change in serum NT-proBNP level	Baseline, after 6 weeks and 12 months
Change in New York Heart Association (NYHA) functional class	Baseline, after 6 weeks and 12 months
Occurrence of cardiovascular related hospitalization	after 6 weeks and 12 months
Occurrence of drug adverse effects	after 6 weeks and 12 months
Occurrence of procedure related complications	after 6 weeks and 12 months
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	Baseline and after 12 months

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Abbott Medical Devices; Leipzig Heart Institute GmbH; Zentrum für Klinische Studien Leipzig
• Investigators: Principal Investigator: Gerhard Hindricks, MD, Heart Center Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): December 30, 2020
• Study Completion (Actual): March 4, 2021

Study Registration Dates

• First Submitted: October 4, 2016
• First Submitted That Met QC Criteria: October 4, 2016
• First Posted (Estimate): October 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 22, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Cardiac Complexes, Premature; Heart Diseases; Premature Birth; Cardiomyopathies; Ventricular Premature Complexes; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Amiodarone
• Other Study ID Numbers: CAT-PVC01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No