Clinical trial NCT02481102: EASYER (EpiAccess SYstem Registry) A Post Market Observational Registry
Official title: EASYER (EpiAccess SYstem Registry) - A Post Market Observational Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Lead sponsor: EpiEP, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are clinically indicated for a procedure requiring pericardial access are eligible for the study.

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.

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

Primary outcomes:
measure: Number of Participants with Adverse Events as Measure of Safety
timeFrame: Up to 4 days post procedure (or until time of discharge)
Secondary outcomes:
measure: Health Economics
timeFrame: Up to 4 days post procedure (or until time of discharge)
Other outcomes:
Locations:
city: New York
country: United States
facility: Vivek Reddy
state: New York
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Texas Cardiac Arrhythmia
state: Texas
Study officials:
affiliation: Texas Cardiac Arrhythmia Research Foundation
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine, Mount Sinai Hospital
name: Vivek Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: