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Trial record 1 of 1 for:    NCT03884660
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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 : April 28, 2023
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.

Tracking Information
First Submitted Date March 19, 2019
First Posted Date March 21, 2019
Last Update Posted Date April 28, 2023
Actual Study Start Date June 18, 2019
Estimated Primary Completion Date April 15, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2019)
  • 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.
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures
 (submitted: March 20, 2019)
  • 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.
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title remedē System Therapy Study
Official Title Prospective Non-randomized Post Market Study Collecting Clinical Data on Safety and Effectiveness of the remedē® System
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Central Sleep Apnea
Intervention Device: remede System
Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 20, 2019)		 500
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 15, 2027
Estimated Primary Completion Date April 15, 2027   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Kimberly Guilbault 260-348-9035 kim.guilbault@zoll.com
Contact: Tsiry Rabemahefa 218-329-7356 tsiry.rabemahefa@zoll.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03884660
Other Study ID Numbers CR1393
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Respicardia, Inc.
Original Responsible Party Same as current
Current Study Sponsor Respicardia, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Kathy McPherson ZOLL Respicardia, Inc.
PRS Account Respicardia, Inc.
Verification Date April 2023