Clinical trial NCT02209064: "EASE" Epicardial Access With the EpiAccess System
Official title: EASe 2- an Epicardial Access Study With the EpiAccess System- A Post-market Follow up Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmias, Cardiac
Keywords: Subxiphoid
Access
Lead sponsor: EpiEP, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-05
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants in Whom Pericardial Access Was Achieved With the EpiAccess System
timeFrame: Through discharge / approx 4 days
Secondary outcomes:
measure: Percentage of Participants in Whom Equivalent or Better Access Was Achieved With EpiAccess System
timeFrame: access through procedure completion
measure: Percentage of Participants With a Pericardial Effusion of >80ml
timeFrame: Access through discharge/approximately 4 days
Other outcomes:
measure: Number of Patients in Whom Pericardial Access Was Achieved With the EpiAccess System
timeFrame: Access through end of procedure
Locations:
city: Prague
country: Czech Republic
facility: Nemocnice Na Homolka
Study officials:
affiliation: University of Debrecen, Cardiology/Electrophysiology Department; Debrecen, Hungary
name: Andrea Natale, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.