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Chronic Evaluation of Respicardia Therapy

NCT01124370 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2016-05-16

Study results available
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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.

Conditions

  • Sleep Disordered Breathing
  • Cheyne Stokes Respiration
  • Periodic Breathing
  • Sleep Apnea
  • Central Sleep Apnea

Interventions

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.

Sponsors & Collaborators

  • Respicardia, Inc.

    lead INDUSTRY

Principal Investigators

  • Piotr Ponikowski, MD · 4th Military Clinical Hospital with Polyclinic, Poland

  • William T Abraham, MD · Ohio State University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States
  • Germany
  • Italy
  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01124370 on ClinicalTrials.gov