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

NCT ID: NCT03087084

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2020-04-01

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.

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Cardiac Pacing and Impedance Measurement system

Group Type: EXPERIMENTAL

Cardiac Pacing and Impedance Measurement system

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic BRC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic Van Heuverswyn, MD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Ashley Chin, MD

Role: PRINCIPAL_INVESTIGATOR

Groote Schuur Hospital

Hielko Miljoen, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Site Status: RECRUITING

Universitair Ziekenhuis Gent

Ghent, , Belgium

Site Status: RECRUITING

Groote Schuur Hospital

Cape Town, , South Africa

Site Status: RECRUITING

Countries

Belgium; South Africa

Central Contacts

Rogier Receveur, Ir

Role: CONTACT

rogier.receveur@medtronic.com

+31-43-35-66-566

Dafni Carmina, Ir

Role: CONTACT

dafni.carmina@medtronic.com

Facility Contacts

Hielko Miljoen, MD

Role: primary

Hielko.Miljoen@uza.be

Frederic Van Heuverswyn, MD

Role: primary

frederic.vanheuverswyn@uzgent.be

Ashley Chin, MD

Role: primary

ashley.chin@uct.ac.za

Other Identifiers

REST-HF

Identifier Type: -

Identifier Source: org_study_id