Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis

Summary

Myocarditis is an inflammatory disease of the heart muscle which is mostly caused by viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. Signs of heart failure (dyspnea, reduced resilience, tendency to edema), thoracic pain, palpitations / arrhythmias / syncope, as well as (potentially) lethal clinical conditions in the sense of a cardiogenic shock or sudden cardiac death can be found.

In 2015, the European Society of Cardiology (ESC) gave a IIa recommendation for the indication of an ICD vest restoration as "bridging" until the acute phase subsides (possibly normalisation of the left ventricular pump function with reduced probability of malignant cardiac arrhythmia) or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical instability. The Monitoring and analysis of malignant cardiac arrhythmias are therefore crucial in the treatment of acute myocarditis.

The aim of this study is to observe the long-term incidence of ventricular arrhythmias in patients diagnosed with myocarditis and to analyze the MRI and echocardiographic data obtained as potential predictive factors for the occurrence of ventricular arrhythmias.

Conditions

• Myocarditis Acute
• Ventricular Arrythmia

Interventions

DEVICE

Biomonitor

Patients receive a Biomonitor only

DEVICE

Life Vest

Patients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally

DEVICE

Implantable Cardioverter-Defibrillator (ICD)

Patients receive an Implantable Cardioverter-Defibrillator (ICD)

Sponsors & Collaborators

• MVZ Leopoldina GmbH

  collaborator OTHER

• Brandenburg Medical School Theodor Fontane

  collaborator OTHER

• Hannover Medical School

  collaborator OTHER

• Wuerzburg University Hospital

  lead OTHER

Principal Investigators

• Peter Nordbeck, MD, PhD · University Hospital Wuerzburg

• Jonas Muentze, MD · University Hospital Wuerzburg

Eligibility

Min Age

18 Years

Max Age

84 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-24

Primary Completion

2022-12-31

Completion

2023-12-31

FDA Device

Yes

Countries

• Germany

Study Locations