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Chronic Evaluation of Respicardia Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Sleep Disordered Breathing Cheyne Stokes Respiration Periodic Breathing Sleep Apnea Central Sleep Apnea | Device: remedē (TM) system | Phase 2 |
| Study Type: | Interventional |
| Study Design: | 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 ]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 ]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 ]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 ]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 ]
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 ]Change = Month 6 score - Baseline score
- NYHA Functional Class Improvement From Baseline to 6 Months [ Time Frame: Baseline and 6 months on therapy ]
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.
| Enrollment: | 57 |
| Study Start Date: | May 2010 |
| Study Completion Date: | August 2014 |
| Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
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.
Other Names:
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Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Candidate is at least 18 years old
-
Candidates with known recent history of Periodic Breathing, as evidenced by an overnight polysomnogram (PSG) within 60 days of the implant procedure demonstrating:
- Apnea-Hypopnea Index (AHI) greater than or equal to 20 events/hr
- Predominantly central origin (central apnea events comprise 50% or more of all apnea events)
- Limited obstructive events (obstructive apneas comprise less than 20% of the AHI)
Exclusion Criteria:
- Candidates who are pregnant
- Candidates with baseline oxygen saturation less than or equal to 90% on a stable FiO2
- Candidates with severe COPD
- Candidates with a history of cerebrovascular accident (CVA), myocardial infarction, coronary artery bypass grafting (CABG) surgery, or percutaneous coronary intervention (PCI) within the 3 months prior to the study
- Candidates with unstable angina
- Candidates with history of primary pulmonary hypertension
Contacts and LocationsPlease 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 | |
| Germany | |
| Heart and Diabetes Center | |
| Bad Oeynhausen, Germany | |
| University of Kiel | |
| Kiel, Germany | |
| Köln University | |
| Köln, Germany | |
| St. Adolf-Stift Hospital | |
| Reinbek, Germany | |
| Italy | |
| Policlinico di Monza-IRCCS | |
| Monza, Italy | |
| Poland | |
| Jagiellonian University | |
| Krakow, Poland | |
| Medical Military Institute | |
| Warsaw, Poland | |
| 4th Military Hospital | |
| Wroclaw, Poland | |
| Principal Investigator: | Piotr Ponikowski, MD | 4th Military Hospital, Poland |
| Principal Investigator: | William T Abraham, MD | Ohio State University |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Respicardia, Inc. |
| ClinicalTrials.gov Identifier: | NCT01124370 History of Changes |
| Other Study ID Numbers: |
Respicardia - Chronic Study I |
| Study First Received: | May 13, 2010 |
| Results First Received: | July 13, 2015 |
| Last Updated: | April 12, 2016 |
Keywords provided by Respicardia, Inc.:
|
Sleep Disordered Breathing Cheyne Stokes Respiration Periodic Breathing Sleep Apnea Central Sleep Apnea |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Respiratory Aspiration Sleep Apnea, Central Cheyne-Stokes Respiration Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on June 23, 2017