EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Arrhythmias, Cardiac
- Sponsor
- EpiEP, Inc.
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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 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.
Investigators
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
Outcomes
Primary Outcomes
Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
Time Frame: Through discharge / approx 4 days
EpiAccess device shall be used to access the pericardial space with measurements tracked noting if access was achieved. The percentage of patients in whom pericardial access was successful will be reported.
Secondary Outcomes
- Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System(access through procedure completion)
- Percentage of Participants With a Pericardial Effusion of >80ml(Access through discharge/approximately 4 days)