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

Lungpacer Medical

Status: Completed

Conditions: Ventilator Induced Lung Injury

Treatments: Device: LIVE Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02670460

TPR-0046 and CLN-0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

24 participants in 1 patient group

Temporary diaphragmatic pacing

Experimental group

Description:

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.

Treatment:

Device: LIVE Catheter