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

NCT02924285 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-07-22

No results posted yet for this study

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.

Conditions

  • Heart Diseases
  • Cardiomyopathies
  • Ventricular Premature Complexes

Interventions

PROCEDURE

Procedure (Radiofrequency catheter ablation)

Radiofrequency catheter ablation

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

Sponsors & Collaborators

  • Helios Health Institute GmbH

    collaborator OTHER

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Zentrum für Klinische Studien Leipzig

    collaborator OTHER

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Gerhard Hindricks, MD · Heart Center Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
87 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2020-12-30
Completion
2021-03-04

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02924285 on ClinicalTrials.gov