search
Back to results

Respicardia, Inc. Pivotal Trial of the remedē System

Primary Purpose

Sleep Apnea, Central, Sleep Disordered Breathing, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Treatment Group (transvenous stimulation of the phrenic nerve)
Control Group (Optimal Medical Therapy)
Sponsored by
Respicardia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Central

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. At least 18 years of age
  2. 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
  3. 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
  4. 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.
  5. In the investigator's opinion, willing and able to comply with all study requirements
  6. Signed the Institutional Review Board/Medical Ethics Committee approved informed consent (HIPAA authorization in the U.S.)

Exclusion Criteria:

  1. Pacemaker dependent subjects without any physiologic escape rhythm
  2. Suspected inability to place catheter for delivery of stimulation lead (e.g. previously know coagulopathy, distorted anatomy, prior failed pectoral implant, etc.)
  3. Evidence of phrenic nerve palsy
  4. More than 2 previous open chest surgical procedures (e.g., CABG)
  5. Etiology of central sleep apnea known to be caused primarily by pain medication
  6. Documented history of psychosis or severe bipolar disorder
  7. Cerebrovascular accident (CVA) within 12 months of baseline testing
  8. History of idiopathic pulmonary hypertension, World Health Organization Class 1
  9. 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
  10. Baseline oxygen saturation less than 92% while awake and on room air after 5 minutes of quiet rest
  11. Anticipated need for chronic oxygen therapy or breathing mask-based therapy for 6 months post therapy initiation visit
  12. Active infection or sepsis within 30 days of enrollment
  13. 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
  14. 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)
  15. Hemoglobin less than 8 gm/dL
  16. In subjects with heart failure, American College of Cardiology (ACC)/American Heart Association Heart (AHA) Stage D
  17. 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
  18. 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
  19. Other anticipated surgery or invasive procedure expected to affect ability to perform testing at 6-month post-therapy initiation visit
  20. Unstable angina
  21. Allergy to or intolerant of contrast dye
  22. Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to remede system implant
  23. Life expectancy or expected time to transplant or left ventricular assist device of less than 12 months
  24. Currently enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial

Sites / Locations

  • Keck Hospital of USC
  • University of Florida - Jacksonville
  • Advocate Medical Group
  • Edward Hospital-Advocate Medical Group
  • University of Maryland, Baltimore
  • Johns Hopkins Bayview Medical Center
  • Detroit Clinical Research Center
  • Spectrum Health
  • United Heart and Vascular (Allina)
  • Mid America Heart Institute
  • Washington University
  • Bryan Heart
  • Cooper Health System
  • Novant Medical Group, Inc. Presbyterian Sleep Health Charlotte
  • Forsyth Medical Center - Novant
  • The Lindner Center for Research and Education at Christ Hospital
  • Ohio State University
  • Lancaster General Hospital
  • Hospital of University of Pennsylvania
  • Stern Cardiovascular
  • Methodist Healthcare System
  • Virginia Commonwealth University
  • Marshfield Clinic
  • Bad Oeynhausen- Heart & Diabetes Center
  • Charite Medical School, Campus Virchow-Klinikum
  • Bernau-Herzzentruym Brandenburg
  • Bielefeld-Klinikun
  • Hamburg: Universitares Herzzentrum
  • Ambulantes Herzzentrum-Kassel
  • Fourth Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Treatment Group

Control group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
March 19, 2013
Last Updated
May 31, 2018
Sponsor
Respicardia, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01816776
Brief Title
Respicardia, Inc. Pivotal Trial of the remedē System
Official Title
A Randomized Trial Evaluating the Safety and Effectiveness of the remedē® System in Patients With Central Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
September 10, 2016 (Actual)
Study Completion Date
November 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respicardia, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Central, Sleep Disordered Breathing, Heart Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control group
Arm Type
Other
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Treatment Group (transvenous stimulation of the phrenic nerve)
Other Intervention Name(s)
remedē System, Transvenous stimulation of the phrenic nerve
Intervention Description
device implant, optimal medical therapy and device initiation 1 month post implant.
Intervention Type
Device
Intervention Name(s)
Control Group (Optimal Medical Therapy)
Other Intervention Name(s)
Optimal Medical Therapy
Intervention Description
device implant, optimal medical therapy and delayed device initiation (7 months post device implant)
Primary Outcome Measure Information:
Title
The Proportion of Participants Experiencing a Reduction in Apnea-hypopnea Index (AHI)
Description
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.
Time Frame
6 months
Title
Freedom From Related Serious Adverse Events Within 12 Months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Central Apnea Index (CAI) Change From Baseline at 6 Months
Description
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.
Time Frame
6 months
Title
Apnea-Hypopnea Index (AHI) Change From Baseline at 6 Months
Description
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.
Time Frame
6 months
Title
Arousal Index (ArI) Change From Baseline at 6 Months
Description
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.
Time Frame
6 months
Title
Rapid Eye Movement (REM) Sleep Change From Baseline at 6 Months
Description
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.
Time Frame
6 months
Title
The Proportion of Participants Experiencing a Marked or Moderate Improvement in Patient Global Assessment at 6 Months
Description
The proportion of subjects with a "moderate" or "marked" improvement in the Patient Global Assessment from baseline to the 6 month visit
Time Frame
6 months
Title
Oxygen Desaturation Index 4% (ODI4) Change From Baseline at 6 Months
Description
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%.
Time Frame
6 months
Title
Epworth Sleepiness Scale (ESS) Change From Baseline at 6 Months
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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.) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Rosa Costanzo, M.D.
Organizational Affiliation
Midwest Heart Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keck Hospital of USC
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
University of Florida - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Advocate Medical Group
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60566
Country
United States
Facility Name
Edward Hospital-Advocate Medical Group
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60566
Country
United States
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Bayview Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Detroit Clinical Research Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Facility Name
Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49525
Country
United States
Facility Name
United Heart and Vascular (Allina)
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Mid America Heart Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bryan Heart
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
Cooper Health System
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Facility Name
Novant Medical Group, Inc. Presbyterian Sleep Health Charlotte
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Forsyth Medical Center - Novant
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
The Lindner Center for Research and Education at Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Stern Cardiovascular
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Methodist Healthcare System
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Marshfield Clinic
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Bad Oeynhausen- Heart & Diabetes Center
City
Bad Oeynhausen
Country
Germany
Facility Name
Charite Medical School, Campus Virchow-Klinikum
City
Berlin
Country
Germany
Facility Name
Bernau-Herzzentruym Brandenburg
City
Bernau
Country
Germany
Facility Name
Bielefeld-Klinikun
City
Bielefeld
Country
Germany
Facility Name
Hamburg: Universitares Herzzentrum
City
Hamburg
Country
Germany
Facility Name
Ambulantes Herzzentrum-Kassel
City
Kassel
Country
Germany
Facility Name
Fourth Military Hospital
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
33953626
Citation
Costanzo MR, Javaheri S, Ponikowski P, Oldenburg O, Augostini R, Goldberg LR, Stellbrink C, Fox H, Schwartz AR, Gupta S, McKane S, Meyer TE, Abraham WT; remede(R)System Pivotal Trial Study Group. Transvenous Phrenic Nerve Stimulation for Treatment of Central Sleep Apnea: Five-Year Safety and Efficacy Outcomes. Nat Sci Sleep. 2021 Apr 29;13:515-526. doi: 10.2147/NSS.S300713. eCollection 2021.
Results Reference
derived
PubMed Identifier
33745107
Citation
Schwartz AR, Goldberg LR, McKane S, Morgenthaler TI. Transvenous phrenic nerve stimulation improves central sleep apnea, sleep quality, and quality of life regardless of prior positive airway pressure treatment. Sleep Breath. 2021 Dec;25(4):2053-2063. doi: 10.1007/s11325-021-02335-x. Epub 2021 Mar 20.
Results Reference
derived
PubMed Identifier
32946372
Citation
Javaheri S, McKane S. Transvenous phrenic nerve stimulation to treat idiopathic central sleep apnea. J Clin Sleep Med. 2020 Dec 15;16(12):2099-2107. doi: 10.5664/jcsm.8802.
Results Reference
derived
PubMed Identifier
32803641
Citation
Costanzo MR. Central Sleep Apnea in Patients with Heart Failure-How to Screen, How to Treat. Curr Heart Fail Rep. 2020 Oct;17(5):277-287. doi: 10.1007/s11897-020-00472-0.
Results Reference
derived
PubMed Identifier
32789619
Citation
Oldenburg O, Costanzo MR, Germany R, McKane S, Meyer TE, Fox H. Improving Nocturnal Hypoxemic Burden with Transvenous Phrenic Nerve Stimulation for the Treatment of Central Sleep Apnea. J Cardiovasc Transl Res. 2021 Apr;14(2):377-385. doi: 10.1007/s12265-020-10061-0. Epub 2020 Aug 12. Erratum In: J Cardiovasc Transl Res. 2022 Jun;15(3):687.
Results Reference
derived
PubMed Identifier
31634407
Citation
Fox H, Oldenburg O, Javaheri S, Ponikowski P, Augostini R, Goldberg LR, Stellbrink C, Mckane S, Meyer TE, Abraham WT, Costanzo MR. Long-term efficacy and safety of phrenic nerve stimulation for the treatment of central sleep apnea. Sleep. 2019 Oct 21;42(11):zsz158. doi: 10.1093/sleep/zsz158.
Results Reference
derived
PubMed Identifier
27598679
Citation
Costanzo MR, Ponikowski P, Javaheri S, Augostini R, Goldberg L, Holcomb R, Kao A, Khayat RN, Oldenburg O, Stellbrink C, Abraham WT; remede System Pivotal Trial Study Group. Transvenous neurostimulation for central sleep apnoea: a randomised controlled trial. Lancet. 2016 Sep 3;388(10048):974-82. doi: 10.1016/S0140-6736(16)30961-8. Epub 2016 Sep 1.
Results Reference
derived
PubMed Identifier
26432647
Citation
Costanzo MR, Augostini R, Goldberg LR, Ponikowski P, Stellbrink C, Javaheri S. Design of the remede System Pivotal Trial: A Prospective, Randomized Study in the Use of Respiratory Rhythm Management to Treat Central Sleep Apnea. J Card Fail. 2015 Nov;21(11):892-902. doi: 10.1016/j.cardfail.2015.08.344.
Results Reference
derived

Learn more about this trial

Respicardia, Inc. Pivotal Trial of the remedē System

We'll reach out to this number within 24 hrs