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Chronic Evaluation of Respicardia Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Respicardia, Inc.
ClinicalTrials.gov Identifier:
NCT01124370
First received: May 13, 2010
Last updated: November 1, 2012
Last verified: April 2011
History of Changes
  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: Allocation: Non-Randomized
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:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by Respicardia, Inc.:

Primary Outcome Measures:
  • AHI Reduction [ Time Frame: 3 months on therapy ] [ Designated as safety issue: No ]
    The primary hypothesis of the study is that the Apnea Hypopnea Index (AHI) after 3 months of therapy will be significantly reduced over baseline.


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    All serious, cardiovascular, pulmonary, and system/implant related adverse events will be evaluated to further characterize the safety of the therapy delivered by the implantable system

  • Quality of Life Results [ Time Frame: 3 months on therapy ] [ Designated as safety issue: No ]

    A battery of qualified instruments will be used to assess quality of life and functional improvements, including:

    • Epworth Sleepiness Scale
    • Minnesota Living with Heart Failure Questionnaire
    • Heart Failure Clinical Composite
    • Six-minute Hall Walk Test
    • NYHA Functional Class

    Subject acclimation and preference assessments will be recorded as well.



Estimated Enrollment: 50
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2013 (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
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
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

No publications provided

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
Last Updated: November 1, 2012
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 Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on June 17, 2013