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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670460
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Lungpacer Medical Inc.

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.

Condition or disease Intervention/treatment Phase
Ventilator Induced Lung Injury Device: LIVE Catheter Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Percutaneous Temporary Placement of a Phrenic Nerve Stimulator for Diaphragm Pacing, a First in Human Trial
Study Start Date : October 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

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 subclavian vein.
Device: LIVE Catheter
Placement of a temporary LIVE Catheter central venous pacing device in the left subclavian vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. Phrenic nerve stimulation in synchrony with MV breaths [ Time Frame: No more than 90 minutes procedure duration ]
    Phrenic nerve stimulation in synchrony with MV breaths as defined by contraction of the diaphragm upon energy delivery.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670460


Locations
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Paraguay
Italian Hospital
Asuncion, Casa Zanotti, Paraguay
Sponsors and Collaborators
Lungpacer Medical Inc.
Investigators
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Study Director: Steve Reynolds, MD Lungpacer Medical
Publications:
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Responsible Party: Lungpacer Medical Inc.
ClinicalTrials.gov Identifier: NCT02670460    
Other Study ID Numbers: TPR-0046 and CLN-0005
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Discussing a publication for FIH
Additional relevant MeSH terms:
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Lung Injury
Ventilator-Induced Lung Injury
Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Wounds and Injuries