EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry
EASYER
1 other identifier
observational
36
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2015
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 18, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedStudy Start
First participant enrolled
June 30, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2021
CompletedFebruary 10, 2021
February 1, 2021
5.6 years
June 18, 2015
February 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 (1)
Health Economics
Up to 4 days post procedure (or until time of discharge)
Eligibility Criteria
Patients who are clinically indicated for a procedure requiring pericardial access are eligible for the study.
You may qualify if:
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EpiEP, Inc.lead
Study Sites (3)
Vivek Reddy
New York, New York, NY 10029, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, PA19104, United States
Texas Cardiac Arrhythmia
Austin, Texas, 78705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Natale, MD
Texas Cardiac Arrhythmia Research Foundation
- PRINCIPAL INVESTIGATOR
Vivek Reddy, MD
Icahn School of Medicine, Mount Sinai Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 4 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 18, 2015
First Posted
June 25, 2015
Study Start
June 30, 2015
Primary Completion
February 9, 2021
Study Completion
February 9, 2021
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share