Janus Feasibility Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-09

Study Completion Date

2025-12-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Transvenous nerve stimulation

Group Type EXPERIMENTAL

Transvenous nerve stimulation

Intervention Type DEVICE

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

Interventions

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Transvenous 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).

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No