"EASE" Epicardial Access With the EpiAccess System

Not Applicable

Completed

• Conditions: Arrhythmias, Cardiac
• Interventions: Device: Pericardial access

• Registration Number: NCT02209064
• Lead Sponsor: EpiEP, Inc.

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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-07-29
• Study First Submitted QC: 2014-08-01
• Study First Posted: 2014-08-05
• Primary Completion: 2015-03
• Study Completion: 2015-11
• Results First Submitted: 2015-11-16
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-08
• Last Update Submitted: 2016-02-08
• Results First Posted: 2016-03-07
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EpiAccess	Pericardial access	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System	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 Outcome Measures

Name	Time	Method
Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System	access through procedure completion	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.
Percentage of Participants With a Pericardial Effusion of >80ml	Access through discharge/approximately 4 days	Secondary endpoint will measure whether or not there was a pericardial effusion greater than 80ml.

Trial Locations

Locations (1)

Nemocnice Na Homolka; 🇨🇿 Prague, Czech Republic