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

Heart Failure Clinical Trial

— REST-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03087084
• Other study ID #: REST-HF
• Status: Recruiting
• Phase: N/A
• Start date: August 7, 2018
• Est. completion date: April 1, 2020

Study information

• Verified date: February 2019
• Source: Medtronic BRC
• Contact: Rogier Receveur, Ir
• Phone: +31-43-35-66-566
• Email: rogier.receveur[@]medtronic.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Universitair Ziekenhuis Gent	Gent
South Africa	Groote Schuur Hospital	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic BRC

Countries where clinical trial is conducted

Belgium,  South Africa, 

Outcome

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