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

This study is currently recruiting participants.
Verified February 2017 by EpiEP, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481102
First Posted: June 25, 2015
Last Update Posted: February 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
EpiEP, Inc.
  Purpose
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.

Condition
Arrhythmias, Cardiac

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Days
Official Title: EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry

Resource links provided by NLM:


Further study details as provided by EpiEP, Inc.:

Primary Outcome Measures:
  • Number of Participants with Adverse Events as Measure of Safety [ Time Frame: Up to 4 days post procedure (or until time of discharge) ]
    Number of Participants with Adverse Events as Measure of Safety


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


Estimated Enrollment: 150
Actual Study Start Date: June 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are clinically indicated for a procedure requiring pericardial access are eligible for the study.
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481102


Contacts
Contact: Claire Williams 978-996-4243 claire@dragonconsultinggroups.com
Contact: Pam Bunes 864-423-2526 pbunes@epiep.com

Locations
United States, Texas
Texas Cardiac Arrhythmia Recruiting
Austin, Texas, United States, 78705
Contact: Andrea Natale, MD    512-458-9410    tcarfan@gmail.com   
Contact: Deb Cardinal    512-458-9410    dscardinal@austinheartbeat.com   
Sponsors and Collaborators
EpiEP, Inc.
Investigators
Principal Investigator: Andrea Natale, MD Texas Cardiac Arrhythmia Research Foundation
Principal Investigator: Vivek Reddy, MD Icahn School of Medicine, Mount Sinai Hospital
  More Information

Responsible Party: EpiEP, Inc.
ClinicalTrials.gov Identifier: NCT02481102     History of Changes
Other Study ID Numbers: QT-0020
First Submitted: June 18, 2015
First Posted: June 25, 2015
Last Update Posted: February 7, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes