Status:
WITHDRAWN
Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea
Lead Sponsor:
Steward St. Elizabeth's Medical Center of Boston, Inc.
Conditions:
Sleep Apnea, Central
Heart Failure
Eligibility:
All Genders
18-85 years
Phase:
NA
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 effic...
Detailed Description
This is a multi-center prospective cohort study to monitor the effect of bilateral phrenic nerve stimulation for treatment of central sleep apnea (CSA) in patients with heart failure. There will be 2 ...
Eligibility Criteria
Inclusion
- 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
- 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.
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Key Trial Info
Start Date :
October 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03238937
Start Date
October 5 2017
End Date
April 29 2019
Last Update
February 27 2020
Active Locations (1)
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1
SEMC
Brighton, Massachusetts, United States, 02135