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Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

NCT03238937 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-02-27

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Phrenic nerve stimulator

Implantation of phrenic nerve stimulator

Sponsors & Collaborators

  • Steward St. Elizabeth's Medical Center of Boston, Inc.

    lead OTHER

Principal Investigators

  • Lana Tsao, MD · Steward St. Elizabeth's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-05
Primary Completion
2019-04-29
Completion
2019-04-29
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03238937 on ClinicalTrials.gov