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

Study Overview
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Brief Summary
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Study conducted to confirm phrenic nerve stimulation using the Lungpacer LIVE Catheter, confirm capture of the diaphragm and confirm that the diaphragm can be paced in synchrony with mechanical ventilator breaths.

Detailed Description
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This study is being conducted to determine if in an anaesthetized (sedated, intubated and mechanically ventilated) subject the LIVE Catheter can be inserted percutaneously and activated via the electrical stimulator to stimulate the left and right phrenic nerves causing the diaphragm to contract in synchrony with mechanical ventilator breaths via phrenic nerve stimulation from a transvenously delivered electrical current.

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

Conditions
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Ventilator Induced Lung Injury

Intervention / Treatment
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* Device: LIVE Catheter


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Temporary diaphragmatic pacing<br>There is no comparator for this study. Single site and all patients are in the treatment allocated group of temporary diaphragmatic pacing with the LIVE Catheter which is inserted via the left subclavian vein. | Device: LIVE Catheter<br>* Placement of a temporary LIVE Catheter central venous pacing device in the left subclavian vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful insertion of the LIVE Catheter into the left subclavian vien | Confirmation by cinefluoroscopy of the insertion of the LIVE Catheter into the Left subclavian vein with the tip located in the superior vena cava | at time of procedure | 
| Absence of device related or procedure related adverse events | Assess subject AE status out to 48 hours post procedure | up to 48 hours or at time of discharge whichever comes first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phrenic nerve stimulation in synchrony with MV breaths | Phrenic nerve stimulation in synchrony with MV breaths as defined by contraction of the diaphragm upon energy delivery. | No more than 90 minutes procedure duration |