Heart FailureREST-HFNCT03087084
RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)
A study testing Cardiac Pacing and Impedance Measurement system in people with Heart Failure, run by Medtronic BRC at 3 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- Cardiac Pacing and Impedance Measurement system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 7 Aug 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 2 countries.
Dafni Carmina, Ir contact
3 sites in 2 countries
Belgium2 sites, 2 recruiting
- Recruiting
Universitair Ziekenhuis Antwerpen
Antwerp, 2650
Hielko Miljoen, MD, Hielko.Miljoen@uza.be
Hielko Miljoen, MD
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
Frederic Van Heuverswyn, MD, frederic.vanheuverswyn@uzgent.be
Frederic MD Van Heuverswyn
South Africa1 site, 1 recruiting
- Recruiting
Groote Schuur Hospital
Cape Town, 7925
Ashley Chin, MD, ashley.chin@uct.ac.za
Ashley Chin, MD
About this study
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
- Being tested
- Cardiac Pacing and Impedance Measurement system
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Pacing and Impedance Measurement systemDevice
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 group | Role | What they receive |
|---|---|---|
| Cardiac Pacing and Impedance Measurement system | Experimental | Not described Receives: Device: Cardiac Pacing and Impedance Measurement system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure
Impedance-derived respiratory rate during different breathing patterns
Measured: Implant
Secondary outcomes (1)
Assess the feasibility of extracting respiratory rate from EGM under various conditions
EGM derived respiratory rate under various conditions.
Measured: Implant and 2 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2017
- Study start7 Aug 2018
- Primary completion1 Apr 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medtronic BRC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederic Van Heuverswyn, MD, Principal investigator, University GhentAshley Chin, MD, Principal investigator, Groote Schuur HospitalHielko Miljoen, MD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03087084
- Sponsor's protocol ID
- REST-HF
- Acronym
- REST-HF
- Status last verified
- Feb 2019
- First submitted
- 17 Feb 2017
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESpiration deTection From Implanted Cardiac Devices in Subjects With Heart Failure (REST-HF)
- ClinicalTrials.gov ID
- NCT03087084
- Acronym / sponsor ID
- REST-HF / REST-HF
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Medtronic BRCIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 22 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Pacing and Impedance Measurement system | Experimental | Device: Cardiac Pacing and Impedance Measurement system |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Pacing and Impedance Measurement systemSubjects 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 | Device | Cardiac Pacing and Impedance Measurement system |
Primary outcome
Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure
Time frame: Implant
Impedance-derived respiratory rate during different breathing patterns
1 secondary outcome
Assess the feasibility of extracting respiratory rate from EGM under various conditions
Time frame: Implant and 2 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dafni Carmina, Ir contact
Frederic Van Heuverswyn, MD principal investigator
University Ghent
Ashley Chin, MD principal investigator
Groote Schuur Hospital
Hielko Miljoen, MD principal investigator
University Hospital, Antwerp
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Pacing and Impedance Measurement system in people with Heart Failure, run by Medtronic BRC at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogier Receveur, Ir (+31-43-35-66-566, rogier.receveur@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of extracting respiratory features from intrathoracic impedance acutely in subjects with heart failure (time frame: Implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2019.