Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea

NCT ID: NCT03238937

Last Updated: 2020-02-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-05
• Study Completion Date: 2019-04-29

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.

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 groups of study patients, both with CSA and heart failure. One group will receive the phrenic nerve pacer, and one will not. Both groups will have the same medical oversight, management, and assessment of heart health whether they receive the pacer or not.

Subjects will have a physical exam, review of medications, New York Heart Association (NYHA) functional classification assessment for heart failure, Minnesota Living With Heart Failure (MLWHF) Questionnaire for quality of live assessment and blood test for Pro-BNP. In-lab sleep study will be required if subject haven't had one within 3 months, and Echocardiogram, if subjects haven't had one within 30 days. If subjects are willing to have stimulator placement procedure, they'll have an ENT consult. Subjects in the procedure arm will have Phrenic Nerve Stimulator placement procedure, and 3 weeks after procedure follow up visit with ENT doctor to activate the device and have sleep study to confirm proper settings.

Conditions

Sleep Apnea, Central; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phrenic Nerve Stimulator

Phrenic Nerve Stimlator

Group Type: OTHER

Phrenic nerve stimulator

Intervention Type: DEVICE

Implantation of phrenic nerve stimulator

no intervention

Patients without phrenic nerve stimulation

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Phrenic nerve stimulator

Implantation of phrenic nerve stimulator

Intervention Type: DEVICE

Other Intervention Names

no intervention / medical management only

Eligibility Criteria

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.

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Lana Tsao

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lana Tsao, MD

Role: PRINCIPAL_INVESTIGATOR

Steward St. Elizabeth's Medical Center

Locations

SEMC

Brighton, Massachusetts, United States

Countries

United States

Other Identifiers

00745

Identifier Type: -

Identifier Source: org_study_id