Sleep Apnea Syndromes
Conditions
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.
Interventions
DEVICETransvenous 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).
Sponsors
Respicardia, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
This is an acute, prospective, non-randomized, single arm IDE feasibility study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
STUDY_DIRECTORKathy A McPherson, RN, MSN
Respicardia, Inc.
Outcome results
None listed