Trial record 2 of 9 for:
respicardia
Respicardia, Inc. Pivotal Trial of the remedē System
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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. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01816776 |
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Recruitment Status :
Completed
First Posted : March 22, 2013
Results First Posted : July 11, 2017
Last Update Posted : June 29, 2018
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Sponsor:
Respicardia, Inc.
Information provided by (Responsible Party):
Respicardia, Inc.
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Brief Summary:
The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remedē® systems.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Sleep Apnea, Central Sleep Disordered Breathing Heart Failure | Device: Treatment Group (transvenous stimulation of the phrenic nerve) Device: Control Group (Optimal Medical Therapy) | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 151 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea |
| Study Start Date : | March 2013 |
| Actual Primary Completion Date : | September 10, 2016 |
| Actual Study Completion Date : | November 7, 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Treatment Group
Subjects implanted with the remedē system device and randomized to the Treatment group will receive optimal medical therapy and have the remedē system initiated to deliver transvenous stimulation of the phrenic nerve at the Therapy Initiation Visit (1 month post device implant).
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Device: Treatment Group (transvenous stimulation of the phrenic nerve)
device implant, optimal medical therapy and device initiation 1 month post implant.
Other Names:
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Control group
Subjects implanted with the remedē system device and randomized to the Control group will receive optimal medical therapy through the 6-month Post-Therapy Initiation Visit. Control group subjects will have the remedē system initiated to deliver transvenous stimulation of the phrenic nerve at the 6-month Post-Therapy Initiation Visit (7 months post device implant).
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Device: Control Group (Optimal Medical Therapy)
device implant, optimal medical therapy and delayed device initiation (7 months post device implant)
Other Name: Optimal Medical Therapy |
Primary Outcome Measures :
- The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI) [ Time Frame: 6 months ]Comparison of the proportion of subjects in the Treatment group achieving a 50% or greater reduction in AHI from baseline to 6 months compared to the Control group.
- Freedom From Related Serious Adverse Events Within 12 Months [ Time Frame: 12 months ]Freedom from serious adverse events (SAEs) associated with the implant procedure, the remede System, or the delivered therapy at 12 months post therapy initiation visit.
Secondary Outcome Measures :
- Central Apnea Index (CAI) Change From Baseline at 6 Months [ Time Frame: 6 months ]Change in CAI = Month 6 index - Baseline index. The central apnea index is a measurement used to indicate the severity of central sleep apnea. It is represented by the number of central apnea events per hour of sleep.
- Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months [ Time Frame: 6 months ]Change in AHI = Month 6 index - Baseline index. The Apnea-Hypopnea Index is a measurement used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
- Arousal Index (ArI) Change From Baseline at 6 Months [ Time Frame: 6 months ]Change in ArI = Month 6 index - Baseline index. The Arousal Index is a measurement used to indicate the number of times per hour of sleep that sleep is disrupted.
- Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months [ Time Frame: 6 months ]Change in REM = Month 6 percentage - Baseline percentage. Rapid Eye Movement (REM) is a sleep stage. A higher percentage of sleep in REM is a measure of better sleep quality.
- The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months [ Time Frame: 6 months ]The proportion of subjects with a "moderate" or "marked" improvement in the Patient Global Assessment from baseline to the 6 month visit
- Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months [ Time Frame: 6 months ]Change in ODI4 = Month 6 index - Baseline index. The Oxygen Desaturation Index 4% is a measurement of the number of times per hour of sleep that the blood's oxygen level drops ≥4%.
- Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months [ Time Frame: 6 months ]Change in ESS = 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- At least 18 years of age
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Central Sleep apnea confirmed by core lab analysis of PSG with EEG within 40 days of scheduled implant:
- Apnea/Hypopnea Index (AHI) greater than or equal to 20;
- Central Apnea Index (CAI) at least 50% of all apneas, with at least 30 central apnea events;
- Oxygen Desaturation Index (OAI) less than or equal to 20% of the total AHI
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Medically stable for 30 days prior to all baseline testing (including PSG), i.e., no hospitalizations for illness, no breathing mask-based therapy, and on stable medications and therapies:
- Stable medications are defined as no changes during this period except for those within a pre-specified sliding scale medication regimen;
- If the subject has heart failure, the baseline testing (including PSG) should occur at least 6 months after initial diagnosis;
- If the subject has systolic heart failure, the baseline testing (including PSG) should occur after maximally titrating beta blockers, angiotensin converting enzyme inhibitors (ACE-I) and other medications indicated in the current guidelines (unless contraindicated or not considered medically necessary) and after receiving any indicated device therapy including devices for cardiac resynchronization therapy and/or primary prevention of sudden cardiac death;
- If subject has a hospitalization or physician visit requiring IV medication between the screening PSG and implant, the subject must be re-screened when stable
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Expected to tolerate study procedures in the opinion of the investigator, in particular:
- Ability to lie down long enough to insert the remede system without shortness of breath and able to tolerate instrumentation for the Polysomnogram/Polygram testing;
- Expected to tolerate therapy titration and the sensation of therapy, and communicate therapy experience.
- In the investigator's opinion, willing and able to comply with all study requirements
- Signed the Institutional Review Board/Medical Ethics Committee approved informed consent (HIPAA authorization in the U.S.)
Exclusion Criteria:
- Pacemaker dependent subjects without any physiologic escape rhythm
- Suspected inability to place catheter for delivery of stimulation lead (e.g. previously know coagulopathy, distorted anatomy, prior failed pectoral implant, etc.)
- Evidence of phrenic nerve palsy
- More than 2 previous open chest surgical procedures (e.g., CABG)
- Etiology of central sleep apnea known to be caused primarily by pain medication
- Documented history of psychosis or severe bipolar disorder
- Cerebrovascular accident (CVA) within 12 months of baseline testing
- History of idiopathic pulmonary hypertension, World Health Organization Class 1
- Limited pulmonary function with either forced expiratory volume (FEV) 1/forced vital capacity (FVC) less than 65% of predicted value or FVC less than 60% of predicted value
- Baseline oxygen saturation less than 92% while awake and on room air after 5 minutes of quiet rest
- Anticipated need for chronic oxygen therapy or breathing mask-based therapy for 6 months post therapy initiation visit
- Active infection or sepsis within 30 days of enrollment
- Currently on renal dialysis or creatinine level greater than 2.5 mg/dL or calculated creatinine clearance equal to or less than 30 ml/min using the Cockcroft-Gault equation
- Poor liver function with baseline aspartate transaminase (AST), alanine transaminase (ALT), and/or total bilirubin greater than 3 times the upper limit of normal (per lab normals at each site)
- Hemoglobin less than 8 gm/dL
- In subjects with heart failure, American College of Cardiology (ACC)/American Heart Association Heart (AHA) Stage D
- Within the 3 months prior to baseline testing, any of the following: uncorrected severe valvular stenosis, valve replacement or repair (percutaneous or surgical), myocardial infarction (MI), coronary artery bypass grafting (CABG) surgery, percutaneous coronary intervention (PCI), cardiac ablation, new cardiac resynchronization device or new pacemaker implant
- New implantable cardioverter defibrillator or any implantable device generator change-out within 30 days prior to baseline testing or anticipated within the first 6 months of enrollment
- Other anticipated surgery or invasive procedure expected to affect ability to perform testing at 6-month post-therapy initiation visit
- Unstable angina
- Allergy to or intolerant of contrast dye
- Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to remede system implant
- Life expectancy or expected time to transplant or left ventricular assist device of less than 12 months
- Currently enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial
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): NCT01816776
Locations
Show 30 study locations
Sponsors and Collaborators
Respicardia, Inc.
Investigators
| Principal Investigator: | Maria Rosa Costanzo, M.D. | Midwest Heart Specialists |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Respicardia, Inc. |
| ClinicalTrials.gov Identifier: | NCT01816776 |
| Other Study ID Numbers: |
Respicardia CR-1005 |
| First Posted: | March 22, 2013 Key Record Dates |
| Results First Posted: | July 11, 2017 |
| Last Update Posted: | June 29, 2018 |
| Last Verified: | May 2018 |
Additional relevant MeSH terms:
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Sleep Apnea Syndromes Sleep Apnea, Central Apnea Respiration Disorders Respiratory Tract Diseases |
Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases |