Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access

Study Overview
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Brief Summary
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Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.

Detailed Description
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The Lungpacer Jugular Access Feasibility System is a prototype for the Lungpacer Diaphragm Pacing Therapy System (DPTS) and consists of the LIVE Catheter, a stimulation system with a Multipole Panel Accessory, an airflow sensor and a Heart Rate Data Capture Device. The catheter is intended for inclusion in the commercial product. The stimulation system with a Multipole Panel Accessory and a Heart Rate Data Capture Device is an interim component created to enable initial safety and feasibility testing of the Lungpacer DPTS concept.

Official Title
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Feasibility of Using a Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access

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: 18 years of age or older; Able and willing to give informed consent or whose legally authorized representative is able and willing to give informed consent; Able to undergo general anesthesia (sedation, intubation, and mechanical ventilation); Acceptable indication for atrial septal defect closure. Exclusion Criteria: Subject has an ejection fraction of < 30% Subject has a co-morbid illness or life expectancy < 2 years Subject has experienced an acute myocardial infarction 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

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: 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 jugular vein. | Device: LIVE Catheter<br>* Placement of a temporary LIVE Catheter central venous pacing device in the left jugular 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 jugular vein and stimulation of phrenic nerves | To determine whether in an anesthetized (sedated, intubated, and mechanically ventilated) patient the LIVE Catheter can be inserted percutaneously in the left jugular vein and, via the electrical stimulator, to transvenously stimulate one or both phrenic nerves causing the diaphragm to contract | through study completion, an average of 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of device related or procedure related adverse events | Assess subject for adverse events status up to 48 hours post procedure | through study completion, an average of 14 days |