Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease (CAT-PVC)
Primary Purpose
Heart Diseases, Cardiomyopathies, Ventricular Premature Complexes
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Procedure (Radiofrequency catheter ablation)
Amiodarone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Diseases
Eligibility 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
Sites / Locations
- Heart Center Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Procedure
Antiarrhythmic Drug
Arm Description
Radiofrequency catheter ablation
Amiodarone
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Change in quality of life (QoL) score according EQ-5D questionnaire
Change in 6 minute walking distance
Change in left ventricular ejection fraction (LVEF)
Change in serum NT-proBNP level
Change in New York Heart Association (NYHA) functional class
Occurrence of cardiovascular related hospitalization
Occurrence of drug adverse effects
Occurrence of procedure related complications
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
Full Information
NCT ID
NCT02924285
First Posted
October 4, 2016
Last Updated
July 21, 2021
Sponsor
University of Leipzig
Collaborators
Helios Health Institute GmbH, Abbott Medical Devices, Zentrum für Klinische Studien Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT02924285
Brief Title
Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease
Acronym
CAT-PVC
Official Title
CAT-PVC Trial Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease: a Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
March 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Leipzig
Collaborators
Helios Health Institute GmbH, Abbott Medical Devices, Zentrum für Klinische Studien Leipzig
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Cardiomyopathies, Ventricular Premature Complexes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Procedure
Arm Type
Active Comparator
Arm Description
Radiofrequency catheter ablation
Arm Title
Antiarrhythmic Drug
Arm Type
Active Comparator
Arm Description
Amiodarone
Intervention Type
Procedure
Intervention Name(s)
Procedure (Radiofrequency catheter ablation)
Intervention Description
Radiofrequency catheter ablation
Intervention Type
Drug
Intervention Name(s)
Amiodarone
Intervention Description
Amiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as:
Antiarrhythmic Drug Amiodarone
Primary Outcome Measure Information:
Title
Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease
Description
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
Time Frame
Baseline and after 6 weeks
Secondary Outcome Measure Information:
Title
Change in quality of life (QoL) score according EQ-5D questionnaire
Time Frame
Baseline, after 6 weeks and 12 months
Title
Change in 6 minute walking distance
Time Frame
Baseline, after 6 weeks and 12 months
Title
Change in left ventricular ejection fraction (LVEF)
Time Frame
Baseline, after 6 weeks and 12 months
Title
Change in serum NT-proBNP level
Time Frame
Baseline, after 6 weeks and 12 months
Title
Change in New York Heart Association (NYHA) functional class
Time Frame
Baseline, after 6 weeks and 12 months
Title
Occurrence of cardiovascular related hospitalization
Time Frame
after 6 weeks and 12 months
Title
Occurrence of drug adverse effects
Time Frame
after 6 weeks and 12 months
Title
Occurrence of procedure related complications
Time Frame
after 6 weeks and 12 months
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerhard Hindricks, MD
Organizational Affiliation
Heart Center Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Heart Center Leipzig
City
Leipzig
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Catheter Ablation Versus Amiodarone for Therapy of Premature Ventricular Contractions in Patients With Structural Heart Disease
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