EASE Epicardial Access With the EpiAccess System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Device: Pericardial access


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: EpiAccess<br>EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician. | Device: Pericardial access<br>* Access to the pericardium to enable further treatments.<br>* Other names: EpiAccess;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System | 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. | Through discharge / approx 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System | EpiAccess will provide equivalent or better access (defined as guidewire entry into the pericardial space) as compared to access with standard of care minimally invasive, subxiphoid access techniques. | access through procedure completion | 
| Percentage of Participants With a Pericardial Effusion of >80ml | Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml. | Access through discharge/approximately 4 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subxiphoid, Access