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

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT03087084
• Lead Sponsor: Medtronic BRC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-17
• Study First Submitted QC: 2017-03-15
• Study First Posted: 2017-03-22
• Study Start: 2018-08-07
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-22
• Last Update Posted: 2019-02-25
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (3)

Universitair Ziekenhuis Antwerpen; 🇧🇪 Antwerpen, Belgium

Universitair Ziekenhuis Gent; 🇧🇪 Gent, Belgium

Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa