EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry

Completed

Conditions studied: Arrhythmias, Cardiac

In brief

The objective of the Registry is to provide post market clinical outcome and potential health economics data and confirm the continued safety of the EpiAccess system.

Key facts

Study ID

NCT02481102

Run by

EpiEP, Inc.

People needed

36

Starts

2015-06-30

Expected to finish

2021-02-09

Last updated by the study team

2021-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is 18 years of age or older
• Pericardial access is clinically indicated
• Patient is willing and able to provide written informed consent

You may not qualify if…

• Patients who have any condition which contraindicates pericardial access or who have any condition specified in the Contraindications section of the Instructions for Use. This includes:
• Previous cardiac surgery or myocardial infarctions resulting in pericardial fibrosis
• Congenital absence of a pericardium
• Absence of a free epicardial space
• Patients with active infection
• History of chronic pericarditis
• Patient requiring anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
• Patient not in normal sinus rhythm
• Presence of thrombus in the left atrium
• Coagulopathy
• Known allergy to contrast media

Where it is running

• Vivek Reddy — New York, New York, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Texas Cardiac Arrhythmia — Austin, Texas, United States

Full record on ClinicalTrials.gov

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