EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry

Completed

• Conditions: Arrhythmias, Cardiac

• Registration Number: NCT02481102
• Lead Sponsor: EpiEP, Inc.

Brief Summary

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.

Detailed Description

The Registry will be a prospective non-randomized single-arm trial of up to 150 patients enrolled in up to ten (10) centers in the United States. The overall duration of the registry is estimated to be 18 months per site. For the patients the registry duration will be from the time of procedure until discharge from the hospital, estimated to be approximately four (4) days.

Prior to enrollment, patients will be evaluated on the basis of the latest available data to establish eligibility. Eligible patients will be considered enrolled in the registry after written informed consent is obtained.

As EpiAccess is only used for the access portion of the procedure, the safety performance and effectiveness endpoints are acute from the time of needle insertion until pericardial sac access is achieved. Follow up clinical examinations will be performed according to institutional standard of care. No special tests are required for this device.

Study Timeline

• Study First Submitted: 2015-06-18
• Study First Submitted QC: 2015-06-24
• Study First Posted: 2015-06-25
• Study Start: 2015-06-30
• Status Verified: 2021-02
• Primary Completion: 2021-02-09
• Study Completion: 2021-02-09
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as Measure of Safety	Up to 4 days post procedure (or until time of discharge)	Number of Participants with Adverse Events as Measure of Safety

Secondary Outcome Measures

Name	Time	Method
Health Economics	Up to 4 days post procedure (or until time of discharge)	Number of Participants with Extended Hospital Stay as a Measure of Health Economic Value

Trial Locations

Locations (3)

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