Clinical trial NCT03087084: RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)
Official title: RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2017-03-22
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.


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.

Primary outcomes:
measure: Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure
timeFrame: Implant
Secondary outcomes:
measure: Assess the feasibility of extracting respiratory rate from EGM under various conditions
timeFrame: Implant and 2 months follow-up
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
Study officials:
affiliation: Universitair Ziekenhuis Gent
name: Frederic Van Heuverswyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Groote Schuur Hospital
name: Ashley Chin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Antwerp
name: Hielko Miljoen, MD
role: PRINCIPAL_INVESTIGATOR
References: