Arrhythmias, Cardiac Clinical Trial
Official title:
EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
Prospective non-randomized, single arm trial to further evaluate the safety and performance of EpiAccess, the study device, for gaining access to the normal, non-distended pericardial space during epicardial diagnostic or therapeutic (ablation) procedures.
Prior to enrolment, patients will be evaluated on the basis of the latest available data to
establish eligibility. Eligible patients will be enrolled in the study by the local
principal investigator after informed consent is obtained.
As EpiAccess is only used for the access portion of electrophysiology procedures, the
safety, performance and effectiveness endpoints are acute from the time of needle insertion
to pericardial space access (guidewire insertion into the pericardial sac). Patients will be
followed until hospital discharge. Follow-up clinical examinations will be performed in
accordance with institutions' standard of care. No special tests are required for this
device. Patients' completion of study will occur at the time of their hospital discharge, or
earlier if patient did not complete the study.
The stop criterion for this study is: greater than 25% Serious Adverse Device Effect, as
defined in this protocol, after enrolment of 10 or more patients, compared to existing data
from the literature presenting epicardial access procedure results during sub-xyphoid
(minimally invasive) surgical procedures.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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