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

September 4, 2018 updated by: Lungpacer Medical Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Paraguay
    • Casa Zanotti
      • Asunción, Casa Zanotti, Paraguay
        • Italian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temporary diaphragmatic pacing
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.
Device: LIVE Catheter
Placement of a temporary LIVE Catheter central venous pacing device in the left jugular vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
through study completion, an average of 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of device related or procedure related adverse events
Time Frame: through study completion, an average of 14 days
Assess subject for adverse events status up to 48 hours post procedure
through study completion, an average of 14 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tidal volume assessement
Time Frame: during the procedure only up to 3 hours
Generation of tidal volume upon delivery of stimulation to the phrenic nerve(s) without spontaneous or ventilator support, as measured by the ventilator
during the procedure only up to 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lungpacer Medical Inc.

Investigators

  • Study Director: Linda Clark, RN, Lungpacer Medical Inc.
  • Principal Investigator: Adrian Ebner, MD, Italian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2018

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

August 30, 2018

Study Registration Dates

First Submitted

May 3, 2018

First Submitted That Met QC Criteria

September 4, 2018

First Posted (Actual)

September 6, 2018

Study Record Updates

Last Update Posted (Actual)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN-0012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Lungpacer may at any time publish the results of and information pertaining to the investigation subject only to compliance with regulatory requirements pertaining to patient protected health information

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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