NCT03238937

Brief Summary

The study objectives are to demonstrate the ease and safety of bilateral cervically implanted phrenic nerve stimulators for Central Sleep Apnea in patients with Heart Failure. To demonstrate the efficacy, both in the short and long term, of implanted phrenic nerve stimulators in patients with Central Sleep Apnea and Heart Failure. Central Sleep Apnea is a form of hypoventilation syndrome, for which this device is FDA approved. We will also determine if the patient's quality and duration of life is improved by using the PNS to treat CSA in heart failure patients.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 3, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

October 5, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2019

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

1.6 years

First QC Date

July 17, 2017

Last Update Submit

February 25, 2020

Conditions

Sleep Apnea, CentralHeart Failure

Outcome Measures

Primary Outcomes (1)

  • Number of participants with treatment related adverse events as assessed by CTCAEv40

    Visual Analog Score for pain, BMI in Kg/m \^2

    2 years

Secondary Outcomes (1)

  • Improvement in quality of life with phrenic nerve stimulation in patients with central sleep apnea and heart failure

    2 years

Study Arms (2)

Phrenic Nerve Stimulator

OTHER

Phrenic Nerve Stimlator

Device: Phrenic nerve stimulator

no intervention

NO INTERVENTION

Patients without phrenic nerve stimulation

Interventions

Phrenic nerve stimulatorDEVICE

Implantation of phrenic nerve stimulator

Also known as: no intervention / medical management only
Phrenic Nerve Stimulator

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Male or female, age 18 to 80 years inclusive.
  • \. New York Heart Association (NYHA) class III or IV, or NYHA class II with an episode of heart failure requiring hospitalization in the past 24 months.
  • \. Stable on guide line directed medical therapy (GDMT) for 30 days prior to enrollment.
  • \. Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of \>15/hour with \>50% being central apneas.
  • \. Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative.

You may not qualify if:

  • Phrenic nerve palsy.
  • Baseline hypoxia (oxygen saturation \<90% on room air).
  • On supplemental oxygen.
  • Severe COPD.
  • Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement.
  • Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
  • Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SEMC

Brighton, Massachusetts, 02135, United States

Location

MeSH Terms

Conditions

Sleep Apnea, CentralHeart Failure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHeart DiseasesCardiovascular Diseases

Study Officials

  • Lana Tsao, MD

    Steward St. Elizabeth's Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

July 17, 2017

First Posted

August 3, 2017

Study Start

October 5, 2017

Primary Completion

April 29, 2019

Study Completion

April 29, 2019

Last Updated

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will share

Will share protocol and study results

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
once the protocol is approved and as data becomes available indefinitively
Access Criteria
via secure website

Locations

US(1)