Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

Description

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.

Study Start Date

September, 29 2017

Estimated Completion Date

July 2022

Interventions

  • Device: Phrenic nerve stimulator

Study ID

Steward St. Elizabeth's Medical Center of Boston, Inc. -- 00745

Status

Recruiting

Trial ID

NCT03238937

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

40

Sponsor

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

Inclusion Criteria

  • 1. Male or female, age 18 to 80 years inclusive. 2. 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. 3. Stable on guide line directed medical therapy (GDMT) for 30 days prior to enrollment. 4. Moderate or severe sleep apnea, that is an Apnea Hypopnea Index (AHI) of >15/hour with >50% being central apneas. 5. 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.

Exclusion Criteria

    1. Phrenic nerve palsy. 2. Baseline hypoxia (oxygen saturation <90% on room air). 3. On supplemental oxygen. 4. Severe COPD. 5. Unstable angina, MI or cardiac procedure within 3 months of phrenic nerve stimulator placement. 6. 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. 7. Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.

Gender

All

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Study Locations and Contact Information (5)

Study Location Distance Name Phone Email
SEMC - Brighton, Massachusetts 2.4 miles Lana Tsao MD None lana.tsao@stweard.com
SEMC - Brighton, Massachusetts 2.4 miles Lana Tsao MD None lana.tsao@stweard.com
SEMC - Brighton, Massachusetts 2.4 miles Lana Tsao MD None lana.tsao@stweard.com
SEMC - Brighton, Massachusetts 2.4 miles Lana Tsao MD None lana.tsao@stweard.com
SEMC - Brighton, Massachusetts 2.4 miles Lana Tsao MD None lana.tsao@stweard.com

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