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:||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 Change From Baseline at 3 Months [ Time Frame: Baseline and 3 months on therapy ] [ Designated as safety issue: No ]Change = Month 3 score - Baseline score The Apnea-Hypopnea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep.
- Related Adverse Events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]The number of subjects with a serious adverse event (SAE) considered related to the remedē system or implant procedure is provided. The number of subjects with a non-SAE related to the remedē system or implant procedure is also provided. Events are included if they occurred on or after the initial implant date through 2 years post implant. A subject may have both SAE and non-SAE events, so the participants with serious events cannot be added to the non-serious participants to get the total number of participants experiencing a related event.
- Epworth Sleepiness Scale Change From Baseline at 6 Months [ Time Frame: Baseline and 6 months on therapy ] [ Designated as safety issue: No ]Change = 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.
- Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months [ Time Frame: Baseline and 6 months on therapy ] [ Designated as safety issue: No ]Change = Month 6 score - Baseline score This questionnaire was for the N=46 patients diagnosed with heart failure. Scores can range from 0-105, with lower scores indicating better quality of life.
- Heart Failure Clinical Composite [ Time Frame: 6 months on therapy ] [ Designated as safety issue: No ]
The composite is determined according to the following definitions.
Worsened: subject died; was hospitalized due to or associated with worsening HF; demonstrated worsening in NYHA class at last observation carried forward; moderate-marked worsening of patient global assessment score at last observation carried forward; or permanently discontinued therapy from the remedē System due to or associated with worsening HF.
Improved: subject did not worsen (as defined above) and demonstrated improvement in NYHA class at last observation carried forward or moderate-marked improvement in patient global assessment score at last observation carried forward.
Unchanged: patient was neither improved nor worsened.
- Six-minute Hall Walk Test Change From Baseline at 6 Months [ Time Frame: Baseline and 6 months on therapy ] [ Designated as safety issue: No ]Change = Month 6 score - Baseline score
- NYHA Functional Class Improvement From Baseline to 6 Months [ Time Frame: Baseline and 6 months on therapy ] [ Designated as safety issue: No ]
Shift in NYHA Class from baseline to 6 months NYHA Class I - Patients with cardiac disease but without resulting limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea or anginal pain.
NYHA Class II - Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, palpitation, dyspnea or anginal pain.
NYHA Class III - Patients with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain.
NYHA Class IV - Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present event at rest. If any physical activity is undertaken, discomfort increases.
|Study Start Date:||May 2010|
|Study Completion Date:||August 2014|
|Primary Completion Date:||August 2014 (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|