Chronic Evaluation of Respicardia Therapy

Phase 2

Completed

Conditions: Sleep Disordered Breathing
Cheyne Stokes Respiration
Periodic Breathing
Sleep Apnea
Central Sleep Apnea

Interventions: Device: remedē (TM) system

Registration Number: NCT01124370

Lead Sponsor: Respicardia, Inc.

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 57

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	remedē (TM) system	All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.

Primary Outcome Measures

Name	Time	Method
AHI Change From Baseline at 3 Months	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.

Secondary Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale Change From Baseline at 6 Months	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.
Related Adverse Events	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.
Heart Failure Clinical Composite	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.
NYHA Functional Class Improvement From Baseline to 6 Months	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.
Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months	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.
Six-minute Hall Walk Test Change From Baseline at 6 Months	Baseline and 6 months on therapy	Change = Month 6 score - Baseline score

Trial Locations

Locations (13): University of Kiel
🇩🇪
Kiel, Germany
Heart and Diabetes Center
🇩🇪
Bad Oeynhausen, Germany
Lancaster Heart and Stroke Foundation
🇺🇸
Lancaster, Pennsylvania, United States
Sentara Cardiovascular Research Institute
🇺🇸
Norfolk, Virginia, United States
Köln University
🇩🇪
Köln, Germany
St. Adolf-Stift Hospital
🇩🇪
Reinbek, Germany
Jagiellonian University
🇵🇱
Krakow, Poland
Medical Military Institute
🇵🇱
Warsaw, Poland
4th Military Hospital
🇵🇱
Wroclaw, Poland
St. Thomas Heart
🇺🇸
Nashville, Tennessee, United States
BryanLGH Heart Institute
🇺🇸
Lincoln, Nebraska, United States
The Ohio State University
🇺🇸
Columbus, Ohio, United States
Policlinico di Monza-IRCCS
🇮🇹
Monza, Italy