- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01124370
Chronic Evaluation of Respicardia Therapy
Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
The purpose of this study is to determine the chronic safety and efficacy of phrenic nerve stimulation on central sleep apnea (CSA). Clinically, CSA events translate into sleep fragmentation, excessive daytime sleepiness, reduced exercise capacity, and possibly ventricular arrhythmias.
The study is chronic in nature, such that subjects will undergo the implantation of an implantable pulse generator and stimulation lead. A sensing lead may also be placed during the initial implant procedure. Subjects will be followed for up to six-months on therapy to assess respiratory and heart failure outcomes. Following the six-month therapy visit, subjects will enter into a long-term follow-up phase until the completion of the study.
It is anticipated that data obtained in this study will show that the proposed intervention can modify respiration with a low incidence of adverse effects. The results of this trial are intended to be used to develop a subsequent protocol for pivotal study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
-
Bad Oeynhausen, Germany
- Heart and Diabetes Center
-
Kiel, Germany
- University of Kiel
-
Köln, Germany
- Köln University
-
Reinbek, Germany
- St. Adolf-Stift Hospital
-
-
-
-
-
Monza, Italy
- Policlinico di Monza-IRCCS
-
-
-
-
-
Krakow, Poland
- Jagiellonian University
-
Warsaw, Poland
- Medical Military Institute
-
Wroclaw, Poland
- 4th Military Hospital
-
-
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68506
- BryanLGH Heart Institute
-
-
Ohio
-
Columbus, Ohio, United States
- The Ohio State University
-
-
Pennsylvania
-
Lancaster, Pennsylvania, United States, 17602
- Lancaster Heart and Stroke Foundation
-
-
Tennessee
-
Nashville, Tennessee, United States
- St. Thomas Heart
-
-
Virginia
-
Norfolk, Virginia, United States, 23507
- Sentara Cardiovascular Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Candidate is at least 18 years old
Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
- Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
- Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
- Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)
Exclusion Criteria:
- Candidates who are pregnant
- Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Candidates with severe COPD
- Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
- Candidates with unstable angina
- Candidates with history of primary pulmonary hypertension
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
All enrolled subjects will undergo attempted system implantation and therapeutic assessment.
Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.
|
Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead.
Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AHI Change From Baseline at 3 Months
Time Frame: Baseline and 3 months on therapy
|
Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea.
It is represented by the number of apnea and hypopnea events per hour of sleep.
|
Baseline and 3 months on therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Related Adverse Events
Time Frame: Up to 2 years
|
The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided.
The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided.
Events are included if they occurred on or after the initial implant date through 2 years post implant.
A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.
|
Up to 2 years
|
Epworth Sleepiness Scale Change From Baseline at 6 Months
Time Frame: Baseline and 6 months on therapy
|
Change = Month 6 score - Baseline score The ESS is an assessment to measure a subject's general level of daytime sleepiness.
Scores can range from 0-24, with higher scores indicating higher level of daytime sleepiness.
|
Baseline and 6 months on therapy
|
Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months
Time Frame: Baseline and 6 months on therapy
|
Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure.
Scores can range from 0-105, with lower scores indicating better quality of life.
|
Baseline and 6 months on therapy
|
Heart Failure Clinical Composite
Time Frame: 6 months on therapy
|
The composite is determined according to the following definitions. Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF. Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward. Unchanged: patient was neither improved nor worsened. |
6 months on therapy
|
Six-minute Hall Walk Test Change From Baseline at 6 Months
Time Frame: Baseline and 6 months on therapy
|
Change = Month 6 score - Baseline score
|
Baseline and 6 months on therapy
|
NYHA Functional Class Improvement From Baseline to 6 Months
Time Frame: Baseline and 6 months on therapy
|
Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain. NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain. NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases. |
Baseline and 6 months on therapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Piotr Ponikowski, MD, 4th Military Hospital
Publications and helpful links
General Publications
- Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195.
- Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Respicardia - Chronic Study I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Sleep Apnea
-
ResMedCRI-The Clinical Research Institute GmbH; University Hospital RegensburgCompletedObstructive Sleep Apnea | Central Sleep Apnea | Mixed Sleep Apnea | Complex Sleep ApneaSwitzerland, Spain, Denmark, Portugal, France, Germany
-
ResMedRWTH Aachen UniversityRecruitingObstructive Sleep Apnea | Central Sleep Apnea | Mixed Sleep ApneaGermany
-
Somnarus IncCompletedObstructive Sleep Apnea | Cheyne-Stokes Respiration | Central Sleep Apnea | Mixed Sleep ApneaUnited States
-
ResMedCompletedObstructive Sleep Apnea | Central Sleep Apnea (Diagnosis) | Chronic Opioid UseUnited States
-
Medtronic - MITGCompletedObstructive Sleep Apnea | Sleep Apnea | Sleep-Disordered Breathing | Central Sleep ApneaUnited States
-
LivaNovaRecruitingApnea | Obstructive Sleep Apnea | OSA | Apnea, Obstructive | Apnea+Hypopnea | Apnea, Obstructive Sleep | Hypopnea, SleepUnited States
-
University of California, Los AngelesRecruiting
-
Brigham and Women's HospitalCompletedObstructive Sleep Apnea (OSA)United States
-
Cleveland Medical Devices IncJohns Hopkins University; The Cleveland Clinic; National Institutes of Health...CompletedObstructive Sleep Apnea | Sleep Disordered Breathing | Central Sleep ApneaUnited States
-
The Hospital for Sick ChildrenRecruitingObstructive Sleep Apnea | Hypoventilation | Central Sleep ApneaCanada
Clinical Trials on remedē (TM) system
-
Zimmer BiometActive, not recruitingOsteoarthritis | Rheumatoid Arthritis | Avascular Necrosis | Post-traumatic Arthritis | Revision Total Shoulder Arthroplasty | Ununited Humeral Head Fracture | Irreducible 3-and 4-part Proximal Humeral Fractures | Gross Rotator Cuff DeficiencyUnited States, United Kingdom
-
CSA Medical, Inc.TerminatedCancer | Pleural NeoplasmsUnited States
-
MetaCure (USA), Inc.TerminatedOverweight | Type 2 Diabetes MellitusUnited States
-
Ethicon, Inc.CompletedConservative Gynecological ProceduresUnited States
-
Abbott Medical DevicesGuidant CorporationCompletedAtherosclerotic Disease, CarotidUnited States
-
3MCompletedTemperature | Body Temperature | ThermosensingUnited States
-
Nyxoah S.A.RecruitingObstructive Sleep ApneaGermany, Belgium, France, Netherlands, Switzerland
-
Aegea Medical, Inc.UnknownMenorrhagiaUnited States, Canada, Mexico, Netherlands
-
Washington University School of MedicineNational Cancer Institute (NCI); National Institutes of Health (NIH); Atrium...CompletedVentral Hernia | AdhesionsUnited States
-
Northwell HealthCompletedSurgical Blood LossUnited States