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Chronic Evaluation of Respicardia Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.
ClinicalTrials.gov Identifier:
NCT01124370
First received: May 13, 2010
Last updated: April 12, 2016
Last verified: April 2016
  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: 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

Resource links provided by NLM:


Further study details as provided by Respicardia, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.



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

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124370

Locations
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
Sponsors and Collaborators
Respicardia, Inc.
Investigators
Principal Investigator: Piotr Ponikowski, MD 4th Military Hospital, Poland
Principal Investigator: William T Abraham, MD Ohio State University
  More Information

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
Health Authority: United States: Food and Drug Administration
Poland: Ministry of Health
Germany: Ministry of Health
Italy: Ministry of Health

Keywords provided by Respicardia, Inc.:
Sleep Disordered Breathing
Cheyne Stokes Respiration
Periodic Breathing
Sleep Apnea
Central Sleep Apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Central
Apnea
Respiratory Aspiration
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 December 06, 2016