Chronic Evaluation of Respicardia Therapy
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.
Sleep Disordered Breathing
Cheyne Stokes Respiration
Central Sleep Apnea
Device: remedē (TM) system
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea|
- AHI Reduction [ Time Frame: 3 months on therapy ] [ Designated as safety issue: No ]The primary hypothesis of the study is that the Apnea Hypopnea Index (AHI) after 3 months of therapy will be significantly reduced over baseline.
- Adverse Events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]All serious, cardiovascular, pulmonary, and system/implant related adverse events will be evaluated to further characterize the safety of the therapy delivered by the implantable system
- Quality of Life Results [ Time Frame: 3 months on therapy ] [ Designated as safety issue: No ]
A battery of qualified instruments will be used to assess quality of life and functional improvements, including:
- Epworth Sleepiness Scale
- Minnesota Living with Heart Failure Questionnaire
- Heart Failure Clinical Composite
- Six-minute Hall Walk Test
- NYHA Functional Class
Subject acclimation and preference assessments will be recorded as well.
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.
Device: remedē (TM) system
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124370
|United States, Nebraska|
|BryanLGH Heart Institute|
|Lincoln, Nebraska, United States, 68506|
|United States, Ohio|
|The Ohio State University|
|Columbus, Ohio, United States|
|United States, Pennsylvania|
|Lancaster Heart and Stroke Foundation|
|Lancaster, Pennsylvania, United States, 17602|
|United States, Tennessee|
|St. Thomas Heart|
|Nashville, Tennessee, United States|
|United States, Virginia|
|Sentara Cardiovascular Research Institute|
|Norfolk, Virginia, United States, 23507|
|Heart and Diabetes Center|
|Bad Oeynhausen, Germany|
|University of Kiel|
|St. Adolf-Stift Hospital|
|Policlinico di Monza-IRCCS|
|Medical Military Institute|
|4th Military Hospital|
|Principal Investigator:||Piotr Ponikowski, MD||4th Military Hospital, Poland|
|Principal Investigator:||William T Abraham, MD||Ohio State University|