EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry (EASYER)

EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac

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 Type: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, NY 10029
      • Vivek Reddy
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, PA19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78705
      • Texas Cardiac Arrhythmia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are clinically indicated for a procedure requiring pericardial access are eligible for the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: EpiEP, Inc.
• Investigators: Principal Investigator: Vivek Reddy, MD, Icahn School of Medicine, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2015
• Primary Completion (Actual): February 9, 2021
• Study Completion (Actual): February 9, 2021

Study Registration Dates

• First Submitted: June 18, 2015
• First Submitted That Met QC Criteria: June 24, 2015
• First Posted (Estimate): June 25, 2015

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 9, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: QT-0020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO