N/A
Completed N=25
"EASE" Epicardial Access With the EpiAccess System
Arrhythmias, Cardiac
Source: ClinicalTrials.gov NCT02209064 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System — 100 percentage of patients
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System |
100 | — |
| SECONDARY Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System |
100 | — |
| SECONDARY Percentage of Participants With a Pericardial Effusion of >80ml |
— | — |
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
- 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
Data sourced from ClinicalTrials.gov (NCT02209064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.