Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT03427333
Eligibility Criteria:
Inclusion Criteria:
* Patient is clinically indicated to undergo a procedure that requires percutaneous access to the normal, non-distended, pericardial space.
* Patient is willing and able to provide written informed consent.
Exclusion Criteria:
* Subject is younger than 18 years of age
* Previous cardiac surgery
* Myocardial infarction within 4 weeks prior to procedure
* Class IV NYHA (New York Heart Association) heart failure symptoms
* Subject with an active systemic infection
* Known carotid artery stenosis greater than 80%
* Presence of thrombus in the left atrium
* Congenital absence of a pericardium
* Coagulopathy
* Hemodynamic Instability
* Acute conditions (i.e. electrolyte abnormality, acute ischemia, drug toxicity)
* Severe hepatic dysfunction or enlargement
* Subject has Body Mass Index \> 40
* Life expectancy less than 6 months
* Subject is pregnant
* Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
* Subject has known or suspected allergy to contrast media
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03427333
Study Brief:
Protocol Section:
NCT03427333