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

Lungpacer Medical

Status: Completed

Conditions: Ventilator-Induced Lung Injury

Treatments: Device: LIVE Catheter

Study type: Interventional

Funder types: Industry

Identifiers

NCT03659552

CLN-0012

Details and patient eligibility

About

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

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 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 jugular vein.

Treatment:

Device: LIVE Catheter