EASYER (EpiAccess SYstem Registry) A Post Market Observat... | NCT02481102

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

NCT02481102

Sponsor

EpiEP, Inc.

Status

Completed

Last Update Posted

Feb 10, 2021Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Arrhythmias, Cardiac

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2015Actual

Primary Completion Date

Feb 9, 2021Actual

Completion Date

Feb 9, 2021Actual

First Submitted Date

Jun 18, 2015

First Submission Date that Met QC Criteria

Jun 24, 2015

First Posted Date

Jun 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 10, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea Natale, MD	Texas Cardiac Arrhythmia Research Foundation	Principal Investigator
Vivek Reddy, MD	Icahn School of Medicine, Mount Sinai Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vivek Reddy		New York	New York	NY 10029	United States
Hospital of the University of Pennsylvania

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001145	Arrhythmias, Cardiac

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided