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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03087084

Acronym

REST-HF

Enrollment

Registered

2017-03-22

Start date

2018-08-07

Completion date

2020-04-01

Last updated

2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

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.

Interventions

DEVICECardiac 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

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.

Design outcomes

Primary

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

Secondary

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

Countries

Belgium, South Africa

Contacts

Primary ContactRogier Receveur, Ir

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

Backup ContactDafni Carmina, Ir

dafni.carmina@medtronic.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026