Skip to main content
OpenTrials
Completed

NCT Number: NCT01124370

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Disordered Breathing Apnea Central Sleep Apnea Cheyne Stokes Respiration Cheyne-Stokes Respiration Dyssomnias Nervous System Diseases Pathological Conditions, Signs and Symptoms Periodic Breathing Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Central Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Heart and Diabetes Center, Bad Oeynhausen, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

remedē (TM) system

Device

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: Respicardia Therapy, Cardiac Concepts Therapy, (note: Respicardia was formerly Cardiac Concepts)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Respicardia, Inc.

Industry

Registry information

Official study title

Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
May 17, 2010
Registry last updated
May 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.