Janus Feasibility Study

Respicardia

Status

Completed

Conditions

Sleep Apnea Syndromes

Treatments

Device: Transvenous nerve stimulation

Study type

Interventional

Funder types

Industry

Identifiers

NCT03985527

CR1389

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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