"EASE" Epicardial Access With the EpiAccess System (EASE2)

EpiEP

Status: Completed

Conditions: Arrhythmias, Cardiac

Treatments: Device: Pericardial access

Study type: Interventional

Funder types: Industry

Identifiers

NCT02209064

DR-002 (rev C)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is 18 years of age or older
2. Pericardial access is clinically indicated
3. Patient is willing and able to provide written informed consent

Exclusion criteria

1. Patient with history of cardiac or pericardial surgery in the past 6 months
2. Patient with history of chronic pericarditis
3. Myocardial infarction within 4 weeks prior to procedure
4. Class IV NYHA (New York Heart Association) heart failure symptoms
5. Cerebrovascular accident within previous 6 months
6. Known carotid artery stenosis greater than 80%
7. Presence of thrombus in the left atrium
8. Coagulopathy
9. Severe Hepatic Dysfunction or Enlargement
10. Life expectancy less than 6 months
11. BMI > 40
12. Patient is enrolled in another clinical trial
13. Patient is pregnant

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

EpiAccess

Other group

Description:

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.

Treatment:

Device: Pericardial access