This trial is active, not recruiting.

Condition arrhythmias and other cardiac conditions needing pericardial access
Treatment pericardial access
Sponsor EpiEP, Inc.
Start date December 2013
End date November 2015
Trial size 50 participants
Trial identifier NCT02209064, DR-002 (rev C)


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
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.
pericardial access EpiAccess
Access to the pericardium to enable further treatments.

Primary Outcomes

Safety Endpoint
time frame: Through discharge / approx 4 days

Secondary Outcomes

Effectiveness endpoint
time frame: access through procedure completion
time frame: Access through discharge/approximately 4 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Epicardial Access Study
Principal investigator Andrea Natale, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by EpiEP, Inc..