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

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

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.

Study Overview

• Status: Completed
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Device: Pericardial access

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czech Republic
  • Prague, Czech Republic
    • Nemocnice Na Homolka

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EpiAccess; 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; Access to the pericardium to enable further treatments.; Other Names: EpiAccess

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System	Number of patients in whom the EpiAccess system was equivalently able to access the pericardial space, compared with standard of care minimally invasive access techniques,documented by using intra procedure or post procedure clinician survey	Access through end of procedure

Collaborators and Investigators

• Sponsor: EpiEP, Inc.
• Investigators: Principal Investigator: Andrea Natale, MD, University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary

Publications and helpful links

General Publications

• Tedrow U, Stevenson WG. Strategies for epicardial mapping and ablation of ventricular tachycardia. J Cardiovasc Electrophysiol. 2009 Jun;20(6):710-3. doi: 10.1111/j.1540-8167.2008.01427.x. Epub 2009 Feb 2.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: July 29, 2014
• First Submitted That Met QC Criteria: August 1, 2014
• First Posted (Estimate): August 5, 2014

Study Record Updates

• Last Update Posted (Estimate): March 7, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Access; Subxiphoid
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: DR-002 (rev C)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO