NCT02924285

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2017

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 4, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

3.2 years

First QC Date

October 4, 2016

Last Update Submit

July 21, 2021

Conditions

Heart DiseasesCardiomyopathiesVentricular Premature Complexes

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (2)

Procedure

ACTIVE COMPARATOR

Radiofrequency catheter ablation

Procedure: Procedure (Radiofrequency catheter ablation)

Antiarrhythmic Drug

ACTIVE COMPARATOR

Amiodarone

Drug: Amiodarone

Interventions

Procedure (Radiofrequency catheter ablation)PROCEDURE

Radiofrequency catheter ablation

Procedure
AmiodaroneDRUG

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

Antiarrhythmic Drug

Eligibility Criteria

Age18 Years - 87 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Center Leipzig

Leipzig, Germany

Location

MeSH Terms

Conditions

Heart DiseasesCardiomyopathiesVentricular Premature Complexes

Interventions

Catheter AblationAmiodarone

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCardiac Complexes, PrematureArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, OperativeBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Gerhard Hindricks, MD

    Heart Center Leipzig

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

November 1, 2017

Primary Completion

December 30, 2020

Study Completion

March 4, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Locations

DE(1)