Janus Feasibility Study

February 27, 2024 updated by: Respicardia, Inc.

Transvenous Nerve Stimulation Study (Janus Study)

The purpose of this feasibility study is to assess whether an alternative transvenous lead location affects respiration and airway physiology during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27013
        • Recruiting
        • Novant Health Forsyth Medical Center
        • Contact:
          • Carla Perez
          • Phone Number: 336-718-5807
        • Principal Investigator:
          • Michael Drucker, MD
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Contact:
          • Sarah Brougher
          • Phone Number: 614-292-3962
        • Principal Investigator:
          • Ralph Augostini, MD
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Recruiting
        • Bryn Mawr Medical Specialists Association
        • Contact:
          • Anne Henry
          • Phone Number: 610-525-1202
        • Principal Investigator:
          • Sheetal Chandhok, MD

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

Yes

Description

Inclusion Criteria:

  • Subject is at least 18 years old
  • Subject with moderate to severe central sleep apnea is undergoing a de novo commercial remedē® System implant procedure or other de novo transvenous cardiac implantable device procedure including a pacemaker or an implantable cardiac defibrillator
  • Subject is willing and able to give informed consent

Exclusion Criteria:

  • Subject is unable or unwilling to participate with study procedures or in the investigator's opinion is medically unstable for the procedure (Medically unstable is defined as when a patient is expected to have worsening health status if additional procedure time is needed)
  • Subject is pregnant or planning to become pregnant (all women with childbearing potential must have a negative pregnancy test within 7 days prior to the implant)
  • Subject is known to be allergic to radio opaque dye which cannot safely be pre-treated per the investigator
  • Subject has body mass index (BMI) > 40 kg/m2 at the time of implant
  • Subject has had prior neck surgery
  • Previous or currently implanted upper airway stimulation device
  • Subject has had prior oral cavity surgery that may interfere with breathing
  • Subject has significant upper airway-related anatomic anomaly
  • Subject is enrolled in concurrent study that may confound the results of this study
  • Subject is taking muscle relaxant medication unless approved by the site implanter and ZOLL Respicardia clinical staff
  • Subject has evidence of nerve weakness/paresis/paralysis or a neurologic disorder that involves the tongue

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: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transvenous nerve stimulation
Device: Transvenous nerve stimulation
Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in respiration and airway physiology
Time Frame: During procedure (immediately post-stimulation)
The primary objective is to assess acute changes in respiration and airway physiology during the respiration cycle during a commercial remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator) implant.
During procedure (immediately post-stimulation)

Collaborators and Investigators

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

Sponsor

Respicardia, Inc.

Investigators

  • Study Director: Kathy A McPherson, RN, MSN, Respicardia, Inc.

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)

January 9, 2020

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

June 7, 2019

First Submitted That Met QC Criteria

June 12, 2019

First Posted (Actual)

June 13, 2019

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR1389

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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