Status:
COMPLETED
"EASE" Epicardial Access With the EpiAccess System
Lead Sponsor:
EpiEP, Inc.
Conditions:
Arrhythmias, Cardiac
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 epi...
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 a...
Eligibility Criteria
Inclusion
- Patient is 18 years of age or older
- Pericardial access is clinically indicated
- Patient is willing and able to provide written informed consent
Exclusion
- Patient with history of cardiac or pericardial surgery in the past 6 months
- Patient with history of chronic pericarditis
- Myocardial infarction within 4 weeks prior to procedure
- Class IV NYHA (New York Heart Association) heart failure symptoms
- Cerebrovascular accident within previous 6 months
- Known carotid artery stenosis greater than 80%
- Presence of thrombus in the left atrium
- Coagulopathy
- Severe Hepatic Dysfunction or Enlargement
- Life expectancy less than 6 months
- BMI \> 40
- Patient is enrolled in another clinical trial
- Patient is pregnant
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02209064
Start Date
December 1 2013
End Date
November 1 2015
Last Update
March 7 2016
Active Locations (1)
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1
Nemocnice Na Homolka
Prague, Czechia