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Janus Feasibility Study

Primary Purpose

Sleep Apnea Syndromes

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Transvenous nerve stimulation

About this trial

This is an interventional basic science trial for Sleep Apnea Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Novant Health Forsyth Medical CenterRecruiting
The Ohio State University Wexner Medical CenterRecruiting
Bryn Mawr Medical Specialists AssociationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Transvenous nerve stimulation

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03985527

First Posted

June 7, 2019

Last Updated

September 28, 2023

Sponsor

Respicardia, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03985527

Brief Title

Janus Feasibility Study

Official Title

Transvenous Nerve Stimulation Study (Janus Study)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2020 (Actual)

Primary Completion Date

March 31, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Respicardia, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea Syndromes

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transvenous nerve stimulation

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Transvenous nerve stimulation

Intervention Description

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

Primary Outcome Measure Information:

Title

Changes in respiration and airway physiology

Description

Time Frame

During procedure (immediately post-stimulation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tsiry Rabemahefa

Phone

9525404470

tsiry.rabemahefa@zoll.com

First Name & Middle Initial & Last Name or Official Title & Degree

Kathy A McPherson

Phone

615-613-6321

kathy.mcpherson@zoll.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathy A McPherson, RN, MSN

Organizational Affiliation

Respicardia, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Novant Health Forsyth Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27013

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carla Perez

Phone

336-718-5807

First Name & Middle Initial & Last Name & Degree

Michael Drucker, MD

Facility Name

The Ohio State University Wexner Medical Center

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Brougher

Phone

614-292-3962

First Name & Middle Initial & Last Name & Degree

Ralph Augostini, MD

Facility Name

Bryn Mawr Medical Specialists Association

City

Bryn Mawr

State/Province

Pennsylvania

ZIP/Postal Code

19010

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anne Henry

Phone

610-525-1202

First Name & Middle Initial & Last Name & Degree

Sheetal Chandhok, MD

12. IPD Sharing Statement

Plan to Share IPD

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Janus Feasibility Study

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