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J Card Fail. 2015 Nov;21(11):892-902. doi: 10.1016/j.cardfail.2015.08.344.

Design of the remedē System Pivotal Trial: A Prospective, Randomized Study in the Use of Respiratory Rhythm Management to Treat Central Sleep Apnea.

Author information

1
Advocate Heart Institute, Naperville, Illinois. Electronic address: mariarosa.costanzo@advocatehealth.com.
2
Division of Cardiology, Department of Medicine, Ohio State University, Columbus, Ohio.
3
Division of Cardiology, Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
4
Department of Heart Diseases, Medical University, Military Hospital, Wroclaw, Poland.
5
Bielefeld Medical Center, Bielefeld, Germany.
6
Sleep physician, Bethesda North Hospital, Cincinnati, Ohio and Professor Emeritus, University of Cincinnati, Cincinnati, Ohio.

Abstract

BACKGROUND:

Central sleep apnea is common in patients with cardiovascular disease and worsens outcomes. There is a lack of established therapies for central sleep apnea, and those available are limited by poor patient adherence and potentially adverse cardiovascular effects, at least in a subset of patients. The remedē System (Respicardia, Minnetonka, Minnesota) is a new physiologic treatment that uses transvenous phrenic nerve stimulation to contract the diaphragm, thereby stabilizing gas exchange and restoring normal breathing throughout the sleep period.

METHODS:

This is a prospective multicenter randomized trial with blinded end points evaluating the safety and efficacy of the remedē System. Up to 173 patients with central sleep apnea will be randomized 1:1 to remedē System therapy initiated at 1 month after implantation (treatment) or to an implanted remedē System that will remain inactive for 6 months (control). Primary efficacy end point is the percentage of patients who experience a reduction in apnea-hypopnea index by a ≥ 50% at 6 months (responder analysis). Primary safety end point is freedom from serious adverse events through 12 months. Secondary end points include sleep-disordered breathing parameters, sleep architecture, Epworth Sleepiness Scale score, and Patient Global Assessment.

CONCLUSIONS:

This is the 1st randomized controlled trial of the safety and efficacy of the remedē System for the treatment of central sleep apnea.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01816776.

KEYWORDS:

Central sleep apnea; phrenic nerve stimulation; randomized controlled trial; sleep

PMID:
26432647
DOI:
10.1016/j.cardfail.2015.08.344
[Indexed for MEDLINE]

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