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Chronic Evaluation of Respicardia Therapy

Primary Purpose

Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
remedē (TM) system
Sponsored by
Respicardia, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disordered Breathing focused on measuring Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • BryanLGH Heart Institute
  • The Ohio State University
  • Lancaster Heart and Stroke Foundation
  • St. Thomas Heart
  • Sentara Cardiovascular Research Institute
  • Heart and Diabetes Center
  • University of Kiel
  • Köln University
  • St. Adolf-Stift Hospital
  • Policlinico di Monza-IRCCS
  • Jagiellonian University
  • Medical Military Institute
  • 4th Military Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.

Outcomes

Primary Outcome Measures

AHI Change From Baseline at 3 Months
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
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
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
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
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
Change = Month 6 score - Baseline score
NYHA Functional Class Improvement From Baseline to 6 Months
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.

Full Information

First Posted
May 13, 2010
Last Updated
April 12, 2016
Sponsor
Respicardia, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01124370
Brief Title
Chronic Evaluation of Respicardia Therapy
Official Title
Safety and Efficacy Evaluation of Respicardia Therapy for Central Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Respicardia, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea
Keywords
Sleep Disordered Breathing, Cheyne Stokes Respiration, Periodic Breathing, Sleep Apnea, Central Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
All enrolled subjects will undergo attempted system implantation and therapeutic assessment. Subjects' baseline assessment values will serve as control parameters for the therapy evaluation.
Intervention Type
Device
Intervention Name(s)
remedē (TM) system
Other Intervention Name(s)
Respicardia Therapy, Cardiac Concepts Therapy, (note: Respicardia was formerly Cardiac Concepts)
Intervention Description
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.
Primary Outcome Measure Information:
Title
AHI Change From Baseline at 3 Months
Description
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.
Time Frame
Baseline and 3 months on therapy
Secondary Outcome Measure Information:
Title
Related Adverse Events
Description
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.
Time Frame
Up to 2 years
Title
Epworth Sleepiness Scale Change From Baseline at 6 Months
Description
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.
Time Frame
Baseline and 6 months on therapy
Title
Minnesota Living With Heart Failure Questionnaire Change From Baseline at 6 Months
Description
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.
Time Frame
Baseline and 6 months on therapy
Title
Heart Failure Clinical Composite
Description
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.
Time Frame
6 months on therapy
Title
Six-minute Hall Walk Test Change From Baseline at 6 Months
Description
Change = Month 6 score - Baseline score
Time Frame
Baseline and 6 months on therapy
Title
NYHA Functional Class Improvement From Baseline to 6 Months
Description
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.
Time Frame
Baseline and 6 months on therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Ponikowski, MD
Organizational Affiliation
4th Military Clinical Hospital with Polyclinic, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William T Abraham, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
BryanLGH Heart Institute
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68506
Country
United States
Facility Name
The Ohio State University
City
Columbus
State/Province
Ohio
Country
United States
Facility Name
Lancaster Heart and Stroke Foundation
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Facility Name
St. Thomas Heart
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
Sentara Cardiovascular Research Institute
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Heart and Diabetes Center
City
Bad Oeynhausen
Country
Germany
Facility Name
University of Kiel
City
Kiel
Country
Germany
Facility Name
Köln University
City
Köln
Country
Germany
Facility Name
St. Adolf-Stift Hospital
City
Reinbek
Country
Germany
Facility Name
Policlinico di Monza-IRCCS
City
Monza
Country
Italy
Facility Name
Jagiellonian University
City
Krakow
Country
Poland
Facility Name
Medical Military Institute
City
Warsaw
Country
Poland
Facility Name
4th Military Hospital
City
Wroclaw
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
30325462
Citation
Javaheri S, McKane SW, Cameron N, Germany RE, Malhotra A. In patients with heart failure the burden of central sleep apnea increases in the late sleep hours. Sleep. 2019 Jan 1;42(1):zsy195. doi: 10.1093/sleep/zsy195.
Results Reference
derived
PubMed Identifier
25770408
Citation
Abraham WT, Jagielski D, Oldenburg O, Augostini R, Krueger S, Kolodziej A, Gutleben KJ, Khayat R, Merliss A, Harsch MR, Holcomb RG, Javaheri S, Ponikowski P; remede Pilot Study Investigators. Phrenic nerve stimulation for the treatment of central sleep apnea. JACC Heart Fail. 2015 May;3(5):360-369. doi: 10.1016/j.jchf.2014.12.013. Epub 2015 Mar 11.
Results Reference
derived

Learn more about this trial

Chronic Evaluation of Respicardia Therapy

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