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

Study Overview
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Brief Summary
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Cardiac Pacing and Impedance Measurement system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cardiac Pacing and Impedance Measurement system<br> | Device: Cardiac Pacing and Impedance Measurement system<br>* 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<br>|

What is the study measuring?
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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 |