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

Primary Purpose

Heart Failure

Status

Unknown status

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Cardiac Pacing and Impedance Measurement system

About this trial

This is an interventional device feasibility trial for Heart Failure

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

Universitair Ziekenhuis AntwerpenRecruiting
Universitair Ziekenhuis GentRecruiting
Groote Schuur HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Pacing and Impedance Measurement system

Arm Description

Outcomes

Primary Outcome Measures

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

Impedance-derived respiratory rate during different breathing patterns

Secondary Outcome Measures

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

EGM derived respiratory rate under various conditions.

Full Information

NCT ID

NCT03087084

First Posted

February 17, 2017

Last Updated

February 22, 2019

Sponsor

Medtronic BRC

1. Study Identification

Unique Protocol Identification Number

NCT03087084

Brief Title

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

Acronym

REST-HF

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

August 7, 2018 (Actual)

Primary Completion Date

April 1, 2020 (Anticipated)

Study Completion Date

April 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic BRC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cardiac Pacing and Impedance Measurement system

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Cardiac Pacing and Impedance Measurement system

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Impedance-derived respiratory rate during different breathing patterns

Time Frame

Implant

Secondary Outcome Measure Information:

Title

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

Description

EGM derived respiratory rate under various conditions.

Time Frame

Implant and 2 months follow-up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rogier Receveur, Ir

Phone

+31-43-35-66-566

rogier.receveur@medtronic.com

First Name & Middle Initial & Last Name or Official Title & Degree

Dafni Carmina, Ir

dafni.carmina@medtronic.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frederic Van Heuverswyn, MD

Organizational Affiliation

Universitair Ziekenhuis Gent

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ashley Chin, MD

Organizational Affiliation

Groote Schuur Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hielko Miljoen, MD

Organizational Affiliation

University Hospital, Antwerp

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitair Ziekenhuis Antwerpen

City

Antwerpen

ZIP/Postal Code

2650

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hielko Miljoen, MD

Hielko.Miljoen@uza.be

First Name & Middle Initial & Last Name & Degree

Hielko Miljoen, MD

Facility Name

Universitair Ziekenhuis Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Frederic Van Heuverswyn, MD

frederic.vanheuverswyn@uzgent.be

First Name & Middle Initial & Last Name & Degree

Frederic MD Van Heuverswyn

Facility Name

Groote Schuur Hospital

City

Cape Town

ZIP/Postal Code

7925

Country

South Africa

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashley Chin, MD

ashley.chin@uct.ac.za

First Name & Middle Initial & Last Name & Degree

Ashley Chin, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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