"EASE" Epicardial Access Study
This trial is active, not recruiting.
|Condition||arrhythmias and other cardiac conditions needing pericardial access|
|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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
|Primary purpose||supportive care|
time frame: Through discharge / approx 4 days
time frame: access through procedure completion
time frame: Access through discharge/approximately 4 days
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
|Official title||Epicardial Access Study|
|Principal investigator||Andrea Natale, MD|
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