Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2026-01-24 @ 2:23 AM
Study NCT ID:
NCT02481102
Status:
COMPLETED
Last Update Posted:
2021-02-10
First Post:
2015-06-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry
Sponsor:
EpiEP, Inc.
Organization:
Study Overview
Official Title:
EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EASYER
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: