Janus Feasibility Study

NCT03985527 | Completed FDA Device

• 1 other identifier: CR1389
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

Brief Summary

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

Outcome Measures

Primary Outcomes (1)

• Changes in respiration and airway physiology

  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)

Study Arms (1)

Transvenous nerve stimulation

EXPERIMENTAL

Device: Transvenous nerve stimulation

Interventions

Transvenous nerve stimulation DEVICE

Acute transvenous nerve stimulation during a commercial implant of remedē® System or commercial transvenous cardiac device (de novo pacemaker or implantable cardiac defibrillator).

Transvenous nerve stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Respicardia, Inc.: lead

Study Sites (3)

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, 27013, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Bryn Mawr Medical Specialists Association

Bryn Mawr, Pennsylvania, 19010, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kathy A McPherson, RN, MSN

  Respicardia, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an acute, prospective, non-randomized, single arm IDE feasibility study.

Study Record Dates

• First Submitted: June 7, 2019
• First Posted: June 13, 2019
• Study Start: January 9, 2020
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)