Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ventilator Induced Lung Injury
- Sponsor
- Lungpacer Medical Inc.
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Absence of device related or procedure related adverse events
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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
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.
Investigators
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)
Outcomes
Primary Outcomes
Absence of device related or procedure related adverse events
Time Frame: up to 48 hours or at time of discharge whichever comes first
Assess subject AE status out to 48 hours post procedure
Successful insertion of the LIVE Catheter into the left subclavian vien
Time Frame: at time of procedure
Confirmation by cinefluoroscopy of the insertion of the LIVE Catheter into the Left subclavian vein with the tip located in the superior vena cava
Secondary Outcomes
- Phrenic nerve stimulation in synchrony with MV breaths(No more than 90 minutes procedure duration)