NCT02209064

"EASE" Epicardial Access With the EpiAccess System

EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: EpiEP, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Arrhythmias, Cardiac

Interventions

Type	Name	Description
DEVICE	Pericardial access	Access to the pericardium to enable further treatments.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-03-01
• Completion: 2015-11-01
• First posted: 2014-08-05
• Last updated: 2016-03-07
• Results posted: 2016-03-07

Locations

1 site across 1 country: Czechia