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remedē System Therapy Study (rēST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03884660
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.

Brief Summary:
The purpose of this non-randomized post market study is to collect clinical data on the safety and effectiveness of the remedē System in a real-world setting.

Condition or disease Intervention/treatment
Central Sleep Apnea Device: remede System

Detailed Description:
This is a multi-center, prospective, open label, non-randomized study to collect safety and effectiveness data in subjects with central sleep apnea implanted with the remedē System. At least 500 subjects will be successfully implanted at approximately 50 sites in the United States and Europe.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
Actual Study Start Date : June 18, 2019
Estimated Primary Completion Date : April 15, 2027
Estimated Study Completion Date : April 15, 2027

Intervention Details:
  • Device: remede System
    Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.


Primary Outcome Measures :
  1. Evaluate safety of the remedē System at implant and protocol required follow up: Percentage of patients with related serious adverse events. [ Time Frame: 5 years ]
    Percentage of patients with related serious adverse events.

  2. Change in Apnea Hypopnea Index (AHI) from baseline [ Time Frame: 1, 3, and 5 years ]
    Evaluate changes in AHI as measured with in-lab polysomnogram (PSG) (1 year) and home sleep apnea test (HSAT) (3 and 5 years)

  3. Change in Epworth Sleepiness Scale (ESS) from baseline [ Time Frame: Baseline, 6 months, and 1, 2, 3, 4 and 5 years ]
    Evaluate changes in daytime sleepiness using the ESS. The ESS total score, an assessment of daytime sleepiness, is the sum of the 8 item-scores.

  4. Change in Patient Reported Outcome Measurement Information System (PROMIS)-29 from baseline [ Time Frame: Baseline, 6 months, and 1, 2, 3, 4 and 5 years ]
    Evaluate impact on the PROMIS-29 questionnaire.

  5. Evaluate overall quality of life using Patient Global Assessment (PGA) [ Time Frame: 6 months and 1 year ]
    Percentage of subjects indicating marked or moderate improvement in PGA.

  6. Change from Baseline in Kansas City Cardiomyopathy Questionnaire KCCQ at 6 months [ Time Frame: Baseline, 6 months, and 1 and 2 years ]
    Evaluate impact on the KCCQ in the heart failure subgroup.

  7. Change in ejection fraction in the subgroup of subjects with heart failure [ Time Frame: 1 year ]
    Evaluate reverse remodeling in the subgroup of subjects with heart failure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are determined to be candidates, independent of this research study, to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry criteria.
Criteria

Subjects who are determined to be candidates to receive a de novo commercial implant of the remedē System are eligible for inclusion in this trial, subject to the entry criteria.

Entry Criteria:

  1. Moderate to severe central sleep apnea (AHI ≥ 15 events per hour) based on a sleep study scored by a local sleep laboratory. It is recommended that a patient have a PSG within 12 months of the expected implant date documenting moderate to severe CSA.
  2. Age 18 years or older
  3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent
  4. In the opinion of the investigator, subject is willing and able to comply with the protocol.
  5. Not currently enrolled in another investigational study or registry that would directly interfere with the current study, except if the subject is participating in a mandatory government registry, or a purely observational registry with no associated treatments. Each instance should be brought to the attention of the sponsor to determine eligibility.
  6. In the opinion of the Investigator, life expectancy exceeds one year.
  7. The subject is not pregnant or planning to become pregnant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884660


Contacts
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Contact: Kimberly Guilbault 260-348-9035 kim.guilbault@zoll.com
Contact: Tsiry Rabemahefa 218-329-7356 tsiry.rabemahefa@zoll.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Respicardia, Inc.
Investigators
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Study Director: Kathy McPherson ZOLL Respicardia, Inc.
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Responsible Party: Respicardia, Inc.
ClinicalTrials.gov Identifier: NCT03884660    
Other Study ID Numbers: CR1393
First Posted: March 21, 2019    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Sleep Apnea, Central
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases