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RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)

NCT03087084 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-02-25

No results posted yet for this study

Summary

The purpose of this prospective, non-randomized, single-arm, research study is to evaluate the accuracy of acutely extracting respiratory rate and tidal volume from implanted cardiac device impedance in subjects with heart failure.

In addition, to assess the feasibility of extracting respiratory rate from device EGM under various conditions.

Conditions

Interventions

DEVICE

Cardiac Pacing and Impedance Measurement system

Subjects indicated for Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator device implant will be requested to perform some respiratory manoeuvres while impedance and electrogram signals are recorded by the system

Sponsors & Collaborators

  • Medtronic BRC

    lead INDUSTRY

Principal Investigators

  • Frederic Van Heuverswyn, MD · University Ghent

  • Ashley Chin, MD · Groote Schuur Hospital

  • Hielko Miljoen, MD · University Hospital, Antwerp

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2020-04-01
Completion
2020-04-01

Countries

  • Belgium
  • South Africa

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 NCT03087084 on ClinicalTrials.gov