NCT03087084

Brief 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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable heart-failure

Timeline
Completed

Started Aug 2018

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed
1.4 years until next milestone

Study Start

First participant enrolled

August 7, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 25, 2019

Status Verified

February 1, 2019

Enrollment Period

1.7 years

First QC Date

February 17, 2017

Last Update Submit

February 22, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure

    Impedance-derived respiratory rate during different breathing patterns

    Implant

Secondary Outcomes (1)

  • Assess the feasibility of extracting respiratory rate from EGM under various conditions

    Implant and 2 months follow-up

Study Arms (1)

Cardiac Pacing and Impedance Measurement system

EXPERIMENTAL
Device: Cardiac Pacing and Impedance Measurement system

Interventions

Cardiac Pacing and Impedance Measurement systemDEVICE

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

Cardiac Pacing and Impedance Measurement system

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject must have heart failure and be undergoing implant of a new or replacement/upgrade Medtronic dual-chamber Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator device for approved indications;
  • Subject must be implanted with an right ventricle lead that supports bipolar pacing and sensing (i.e. a true bipolar defibrillation lead);
  • Subject must receive a light conscious sedation or no sedation where breathing maneuvers can be performed and evaluated during the implant;
  • Subject must be willing to provide Informed Consent for their participation in the study;
  • Subject must be ≥ 18 years of age.

You may not qualify if:

  • Subjects who are unable or unwilling to voluntarily participate in any visit required by the study and to provide consent;
  • Subject has congenital heart disease;
  • Subject has a tachyarrhythmia (atrial and/or ventricular) at the time of enrollment and a cardioversion will not be attempted prior to the research procedure;
  • Subject has unstable coronary artery disease;
  • Subject requires cardiac pacing at rest for rate support;
  • Subject presents any concomitant conditions which in the opinion of the investigator would not allow a proper execution of the respiratory exercises as per protocol;
  • Subject presents any concomitant condition which in the opinion of the investigator would not allow a safe participation in the study;
  • Subject is pregnant or breast feeding;
  • Subject is legally incompetent;
  • Subject is enrolled in a concurrent study that may confound the results of this study without documented pre-approval from Medtronic study manager.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Universitair Ziekenhuis Antwerpen

Antwerp, 2650, Belgium

RECRUITING

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

RECRUITING

Groote Schuur Hospital

Cape Town, 7925, South Africa

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Frederic Van Heuverswyn, MD

    University Ghent

    PRINCIPAL INVESTIGATOR

  • Ashley Chin, MD

    Groote Schuur Hospital

    PRINCIPAL INVESTIGATOR

  • Hielko Miljoen, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rogier Receveur, Ir

CONTACT

+31-43-35-66-566rogier.receveur@medtronic.com

Dafni Carmina, Ir

CONTACT

dafni.carmina@medtronic.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2017

First Posted

March 22, 2017

Study Start

August 7, 2018

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

February 25, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)ZA(1)