Clinical trial NCT03659552: Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Official title: Feasibility of Using a Percutaneous Temporary Placement of a Transvenous Phrenic Nerve Stimulator for Diaphragm Pacing Using Jugular Access
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator-Induced Lung Injury
Lead sponsor: Lungpacer Medical Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group assignment
Primary purpose: DEVICE_FEASIBILITY

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.

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)
* 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.

Primary outcomes:
measure: Successful insertion of the LIVE Catheter into the left jugular vein and stimulation of phrenic nerves
timeFrame: through study completion, an average of 14 days
Secondary outcomes:
measure: Absence of device related or procedure related adverse events
timeFrame: through study completion, an average of 14 days
Other outcomes:
measure: Tidal volume assessement
timeFrame: during the procedure only up to 3 hours
Locations:
city: Asunción
country: Paraguay
facility: Italian Hospital
state: Casa Zanotti
Study officials:
affiliation: Lungpacer Medical Inc.
name: Linda Clark, RN
role: STUDY_DIRECTOR
affiliation: Italian Hospital
name: Adrian Ebner, MD
role: PRINCIPAL_INVESTIGATOR
References:
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