"EASE" Epicardial Access With the EpiAccess System

Arrhythmias, Cardiac Clinical Trial

— EASE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209064
• Other study ID #: DR-002 (rev C)
• Status: Completed
• Phase: N/A
• First received: July 29, 2014
• Last updated: February 8, 2016
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: February 2016
• Source: EpiEP, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: November 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arrhythmias, Cardiac

Intervention

Device:
• Pericardial access
Access to the pericardium to enable further treatments.

Locations

Country	Name	City	State
Czech Republic	Nemocnice Na Homolka	Prague

Sponsors (1)

Lead Sponsor	Collaborator
EpiEP, Inc.

Country where clinical trial is conducted

Czech Republic, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No
Secondary	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	Yes