Janus Feasibility Study

Description

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.

Conditions

Sleep Apnea Syndromes

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Study Overview

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Study Details

Study overview

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.

Transvenous Nerve Stimulation Study (Janus Study)

Janus Feasibility Study

Condition
Sleep Apnea Syndromes
Intervention / Treatment

-

Contacts and Locations

Winston-Salem

Novant Health Forsyth Medical Center, Winston-Salem, North Carolina, United States, 27013

Columbus

The Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Bryn Mawr

Bryn Mawr Medical Specialists Association, Bryn Mawr, Pennsylvania, United States, 19010

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Respicardia, Inc.,

Kathy A McPherson, RN, MSN, STUDY_DIRECTOR, Respicardia, Inc.

Study Record Dates

2025-06-30