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Respicardia, Inc. Pivotal Trial of the remedē System

NCT01816776 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2018-06-29

Study results available
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Summary

The primary purpose of this prospective, multicenter, randomized trial is to evaluate the safety and effectiveness of therapy delivered by the remedē® system in subjects with moderate to severe central sleep apnea and optimal medical management, compared to outcomes in randomized control subjects receiving optimal medical management and implanted but inactive remedē® systems.

Conditions

Interventions

DEVICE

Treatment Group (transvenous stimulation of the phrenic nerve)

device implant, optimal medical therapy and device initiation 1 month post implant.

DEVICE

Control Group (Optimal Medical Therapy)

device implant, optimal medical therapy and delayed device initiation (7 months post device implant)

Sponsors & Collaborators

  • Respicardia, Inc.

    lead INDUSTRY

Principal Investigators

  • Maria Rosa Costanzo, M.D. · Midwest Heart Specialists

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-03-31
Primary Completion
2016-09-10
Completion
2017-11-07

Countries

  • United States
  • Germany
  • 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 NCT01816776 on ClinicalTrials.gov