Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial

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 enro…