Respicardia, Inc. Pivotal Trial of the remedē System

Completed · Not applicable

Conditions studied: Sleep Apnea, Central, Sleep Disordered Breathing, Heart Failure

In brief

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.

Key facts

Study ID

NCT01816776

Run by

Respicardia, Inc.

People needed

151

Starts

2013-03-01

Expected to finish

2017-11-07

Last updated by the study team

2018-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• 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
• 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
• 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.)

You may not qualify if…

• 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

Where it is running

• Keck Hospital of USC — Los Angeles, California, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• Advocate Medical Group — Downers Grove, Illinois, United States
• Edward Hospital-Advocate Medical Group — Naperville, Illinois, United States
• University of Maryland, Baltimore — Baltimore, Maryland, United States
• Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States
• Detroit Clinical Research Center — Farmington Hills, Michigan, United States
• Spectrum Health — Grand Rapids, Michigan, United States
• United Heart and Vascular (Allina) — Saint Paul, Minnesota, United States
• Mid America Heart Institute — Kansas City, Missouri, United States
• Washington University — St Louis, Missouri, United States
• Bryan Heart — Lincoln, Nebraska, United States
• Cooper Health System — Cherry Hill, New Jersey, United States
• Novant Medical Group, Inc. Presbyterian Sleep Health Charlotte — Charlotte, North Carolina, United States
• Forsyth Medical Center - Novant — Winston-Salem, North Carolina, United States
• The Lindner Center for Research and Education at Christ Hospital — Cincinnati, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Lancaster General Hospital — Lancaster, Pennsylvania, United States
• Hospital of University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Stern Cardiovascular — Memphis, Tennessee, United States
• Methodist Healthcare System — San Antonio, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Bad Oeynhausen- Heart & Diabetes Center — Bad Oeynhausen, Germany
• Charite Medical School, Campus Virchow-Klinikum — Berlin, Germany

Full record on ClinicalTrials.gov

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