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.
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
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.
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
- Patients who have any condition which contraindicates pericardial access or who have
any condition specified in the Contraindications section of the Instructions for Use.
- 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
- Patient not in normal sinus rhythm
- Presence of thrombus in the left atrium
- Known allergy to contrast media