Janus Feasibility Study

Not Applicable

Recruiting

• Conditions: Sleep Apnea Syndromes

• Registration Number: NCT03985527
• Lead Sponsor: Respicardia, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-07
• Study First Submitted QC: 2019-06-12
• Study First Posted: 2019-06-13
• Study Start: 2020-01-09
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-11
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-03-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in respiration and airway physiology	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.

Trial Locations

Locations (3)

Novant Health Forsyth Medical Center; 🇺🇸 Winston-Salem, North Carolina, United States

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

Bryn Mawr Medical Specialists Association; 🇺🇸 Bryn Mawr, Pennsylvania, United States