Crome/Cobalt Respiration Study

An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The goal of this study is to compare measured respiration rates in various subject scenarios and use conditions between capnography and the Crome and Cobalt ICD and CRT-D MRI SureScan devices (derived using a Holter recorder). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Heart Failure
What is being tested?: Enabling Sensor Research Holter Mode feature
Type of treatment: Medical device
How many people: 61 participants
Where: 4 sitesUnited States
Study dates: 21 Nov 2023to 12 Jun 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The target population for this study will include adult subjects who are ≥18 years of age, who have an active, implanted Crome or Cobalt ICD or CRT-D system that's been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT), and who do not have any contraindications that would impact their ability to complete the required breathing and exercise activities, which aligns with the key eligibility criteria for the study. A minimum of 30% of all enrolled subjects will have a documented history of heart failure and a minimum of 20% of all enrolled subjects will be female (as identified at birth).

Who may be able to join

Subject has an active CromeTM or CobaltTM ICD or CRT-D MRI SureScanTM system which has been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT)
Subject is implanted with one of the following models of a true bipolar right ventricular lead manufactured by Medtronic:
Model 6946M
Model 6947
Model 6947M
Model 6935

Show all 10Show fewer

Model 6935M
Subject is ≥ 18 years of age
Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
Subject is willing and able to comply with study procedures

Who cannot join

Subject has existing condition that necessitates the use of supplemental oxygen
Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator
Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
Subject has an active or suspected lead integrity issue, in the opinion of the investigator
Subject is enrolled in another study that could confound the results of this study
Subject has NYHA Class IV heart failure

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705-1852
Hartford Hospital
Hartford, Connecticut, 06102
South Oklahoma Heart Research
Oklahoma City, Oklahoma, 73135
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303-1900

Other trials in United States

About this study

Read the detailed description

This study will enroll subjects who have already received a Medtronic Crome or Cobalt ICD or CRT-D MRI SureScan device and who meet all of the inclusion criteria and none of the exclusion criteria. Subjects will be asked to complete various breathing/exercise activities while connected to a capnography monitor and a Holter recorder and respiration rates from both devices will be compared for accuracy, with the capnography monitor being the source of truth.

Conditions: Heart Failure
Being tested: Enabling Sensor Research Holter Mode feature
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Enabling Sensor Research Holter Mode featureDevice
The Sensor Research Holter Mode feature within the Crome and Cobalt ICD and CRT-D devices will be enabled for a short period of time at the In-clinic Testing Visit to allow for desired data collection.

Study groups in NCT06089694
Study group	Role	What they receive
All Enrolled Subjects		In-clinic Testing Visit: All enrolled subjects will have a Holter recorder, capnography monitor and SpO2 sensor applied and will undergo various breathing/exercise activities. Subjects will go home connected to the Holter recorder for 24 hours for collection of ambulatory data. Receives: Device: Enabling Sensor Research Holter Mode feature

What is being measured

The primary outcome is the main question the study is designed to answer.

Daily Capnography Respiration Rate
Daily respiration rates will be calculated using a series of paired device-derived respiration rates and capnography waveform-derived respiration rates, where the capnography respiration rate will be the source of truth. The differences in these daily respiration rates will be evaluated to determine whether the daily device-derived respiration rate accuracy is acceptable (i.e., consistently within +/- 3 breaths per minute of the true respiration rate).
Measured: During In-clinic Testing Visit, an average of 2 hours
Daily Device-derived Respiration Rate
Daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
Measured: During In-clinic Testing Visit, an average of 2 hours
Difference in Respiration Rate
Difference between the daily respiration rate determined using capnography and the daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
Measured: During In-clinic Testing Visit, an average of 2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202312 Jun 2024

First posted18 Oct 2023
Study start21 Nov 2023
Primary completion12 Jun 2024
Study completion12 Jun 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06089694
Sponsor's protocol ID: MDT22030
Status last verified: Aug 2024
First submitted: 9 Oct 2023
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
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Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
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Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Assessment of CCM in HF With Higher Ejection Fraction
Heart Failure, Heart Failure With Preserved Ejection Fraction

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Crome/Cobalt Respiration Study
ClinicalTrials.gov ID: NCT06089694
Acronym / sponsor ID: MDT22030
Conditions: Heart Failure
Study type: Observational
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: 21 Nov 2023 (actual)
Primary completion: 12 Jun 2024 (actual)
Study completion: 12 Jun 2024 (actual)
First posted: 18 Oct 2023 (actual)
Results: Posted 21 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
All Enrolled Subjects	–	Device: Enabling Sensor Research Holter Mode featureIn-clinic Testing Visit: All enrolled subjects will have a Holter recorder, capnography monitor and SpO2 sensor applied and will undergo various breathing/exercise activities. Subjects will go home connected to the Holter recorder for 24 hours for collection of ambulatory data.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The target population for this study will include adult subjects who are ≥18 years of age, who have an active, implanted Crome or Cobalt ICD or CRT-D system that's been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT), and who do not have any contraindications that would impact their ability to complete the required breathing and exercise activities, which aligns with the key eligibility criteria for the study. A minimum of 30% of all enrolled subjects will have a documented history of heart failure and a minimum of 20% of all enrolled subjects will be female (as identified at birth).

Key inclusion criteria (10 listed)

Subject has an active CromeTM or CobaltTM ICD or CRT-D MRI SureScanTM system which has been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT)
Subject is implanted with one of the following models of a true bipolar right ventricular lead manufactured by Medtronic:
Subject is ≥ 18 years of age
Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
Subject is willing and able to comply with study procedures

Key exclusion criteria (6 listed)

Subject has existing condition that necessitates the use of supplemental oxygen
Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator
Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
Subject has an active or suspected lead integrity issue, in the opinion of the investigator
Subject is enrolled in another study that could confound the results of this study

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
Enabling Sensor Research Holter Mode featureThe Sensor Research Holter Mode feature within the Crome and Cobalt ICD and CRT-D devices will be enabled for a short period of time at the In-clinic Testing Visit to allow for desired data collection.	Device	All Enrolled Subjects

Primary outcome

Daily Capnography Respiration Rate
Time frame: During In-clinic Testing Visit, an average of 2 hours
Daily respiration rates will be calculated using a series of paired device-derived respiration rates and capnography waveform-derived respiration rates, where the capnography respiration rate will be the source of truth. The differences in these daily respiration rates will be evaluated to determine whether the daily device-derived respiration rate accuracy is acceptable (i.e., consistently within +/- 3 breaths per minute of the true respiration rate).
Daily Device-derived Respiration Rate
Time frame: During In-clinic Testing Visit, an average of 2 hours
Daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
Difference in Respiration Rate
Time frame: During In-clinic Testing Visit, an average of 2 hours
Difference between the daily respiration rate determined using capnography and the daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.

Results and safety

Results posted to the registry on 21 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Subjects	61	61

Primary outcome: Daily Capnography Respiration Rate

Time frame: During In-clinic Testing Visit, an average of 2 hours. Mean (Standard Deviation). Unit: breaths per minute

Measure	All Enrolled Subjects n = 44
Value	15.3 (3.7)

Population analysed: 15 subjects were used to generate the algorithm and not included in the primary endpoint analysis. 2 subjects did not have usable data.

Primary outcome: Daily Device-derived Respiration Rate

Time frame: During In-clinic Testing Visit, an average of 2 hours. Mean (Standard Deviation). Unit: breaths per minute

Measure	All Enrolled Subjects n = 44
Value	15.5 (3.5)

Population analysed: 15 subjects were used to generate the algorithm and not included in the primary endpoint analysis. 2 subjects did not have usable data.

Primary outcome: Difference in Respiration Rate

Time frame: During In-clinic Testing Visit, an average of 2 hours. Mean (Standard Deviation). Unit: breaths per minute

Measure	All Enrolled Subjects n = 44
Value	0.2 (1.1)

Population analysed: 15 subjects were used to generate the algorithm and not included in the primary endpoint analysis. 2 subjects did not have usable data.

Adverse events

Time frame: All adverse events (AEs) were collected from the time the subject signed informed consent through study exit, which on average lasted 2 days, Study lasted 7 months in all.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Subjects	0 of 61 (0%)	0 of 61 (0%)	0 of 61

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
RecruitingObservational study
Changes in Skeletal Muscle Thickness in Patients With Acute Heart Failure
Heart Failure, Muscle Atrophy
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
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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.

The record lists no contact. Use the official record to reach the sponsor.

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 4 sites in United States.

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 10 inclusion and 6 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: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. 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?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Daily Capnography Respiration Rate (time frame: During In-clinic Testing Visit, an average of 2 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06089694.

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 21 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.