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 @ 2:09 AM
Ignite Modification Date:
2025-12-25 @ 2:09 AM
NCT ID:
NCT02670460
Eligibility Criteria:
Inclusion Criteria:
* Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent.
* Able to undergo general anaesthesia (sedation, intubation and mechanical ventilation)
* Susceptible indication for atrial septal defect closure
Exclusion Criteria:
* Subject has an EF of \< 30%
* Subject has a co-morbid illness or life expectancy \< 2 years
* Subject has experienced an AMI within 72 hours prior to this procedure
* Subject is contraindicated for or unwilling to take aspirin or anticoagulants
* Subject is in cardiogenic shock
* Subject has other cardiovascular disease requiring open heart surgery
* Subject is known to have a demonstrated intra cardiac thrombus on echocardiography
* Subject has been treated with paralytic medications within 72 hours prior to procedure
* Subject has significant thoracic abnormalities such that placement of a left subclavian line would be difficult
* Inability to cannulate the left subclavian vein (post-consent exclusion)
* Subject has a known or suspected phrenic nerve paralysis
* Subject has co-existing temporary or implanted cardiac electrical devices such as a pacemaker or defibrillator
* Subject has an active systemic infection or local infection at or around the insertion site
* Subject is known or suspected to be pregnant or is lactating
* Subject will be unavailable for, or is unwilling to comply with, follow up requirements of the protocol
* Subject is currently enrolled in any other study of an investigational drug or device who has received treatment under that protocol with the investigational product during the 30 days prior to screening.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02670460
Study Brief:
Protocol Section:
NCT02670460