Feasibility of Using a Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator-Induced Lung Injury
- Sponsor
- Lungpacer Medical Inc.
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Successful insertion of the LIVE Catheter into the left jugular vein and stimulation of phrenic nerves
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
Study conducted to confirm phrenic nerve stimulation using the a transvenous Phrenic Nerve Stimulator in the left jugular vein.
Detailed Description
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Successful insertion of the LIVE Catheter into the left jugular vein and stimulation of phrenic nerves
Time Frame: through study completion, an average of 14 days
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
Secondary Outcomes
- Absence of device related or procedure related adverse events(through study completion, an average of 14 days)