EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry

Arrhythmias, Cardiac Clinical Trial

— EASYER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02481102
• Other study ID #: QT-0020
• Status: Completed
• Start date: June 30, 2015
• Est. completion date: February 9, 2021

Study information

• Verified date: February 2021
• Source: EpiEP, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 9, 2021
• Est. primary completion date: February 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia	Austin	Texas
United States	Vivek Reddy	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
EpiEP, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)