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

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.

Study Overview

• Status: Unknown
• Conditions: Heart Failure
• Intervention / Treatment: Device: Cardiac Pacing and Impedance Measurement system

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rogier Receveur, Ir; Phone Number: +31-43-35-66-566; Email: rogier.receveur@medtronic.com
• Study Contact Backup: Name: Dafni Carmina, Ir; Email: dafni.carmina@medtronic.com

Study Locations

• Belgium
  • Antwerpen, Belgium, 2650
    • Recruiting
    • Universitair Ziekenhuis Antwerpen
    • Contact: Hielko Miljoen, MD; Email: Hielko.Miljoen@uza.be
    • Principal Investigator: Hielko Miljoen, MD
  • Gent, Belgium, 9000
    • Recruiting
    • Universitair Ziekenhuis Gent
    • Contact: Frederic Van Heuverswyn, MD; Email: frederic.vanheuverswyn@uzgent.be
    • Principal Investigator: Frederic MD Van Heuverswyn
• South Africa
  • Cape Town, South Africa, 7925
    • Recruiting
    • Groote Schuur Hospital
    • Contact: Ashley Chin, MD; Email: ashley.chin@uct.ac.za
    • Principal Investigator: Ashley Chin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cardiac Pacing and Impedance Measurement system	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure	Impedance-derived respiratory rate during different breathing patterns	Implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the feasibility of extracting respiratory rate from EGM under various conditions	EGM derived respiratory rate under various conditions.	Implant and 2 months follow-up

Collaborators and Investigators

• Sponsor: Medtronic BRC
• Investigators: Principal Investigator: Frederic Van Heuverswyn, MD, Universitair Ziekenhuis Gent; Principal Investigator: Ashley Chin, MD, Groote Schuur Hospital; Principal Investigator: Hielko Miljoen, MD, University Hospital, Antwerp

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2018
• Primary Completion (Anticipated): April 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: February 17, 2017
• First Submitted That Met QC Criteria: March 15, 2017
• First Posted (Actual): March 22, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2019
• Last Update Submitted That Met QC Criteria: February 22, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: REST-HF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No