Trial Outcomes & Findings for Crome/Cobalt Respiration Study (NCT NCT06089694)
NCT ID: NCT06089694
Last Updated: 2026-07-21
Results Overview
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).
Recruitment status
COMPLETED
Target enrollment
61 participants
Primary outcome timeframe
During In-clinic Testing Visit, an average of 2 hours
Results posted on
2026-07-21
Participant Flow
Participant milestones
| Measure |
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.
Enabling Sensor Research Holter Mode feature: 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.
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|---|---|
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Overall Study
STARTED
|
61
|
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Overall Study
COMPLETED
|
61
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Includes the 54 patients who had heart failure
Baseline characteristics by cohort
| Measure |
All Enrolled Subjects
n=61 Participants
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.
Enabling Sensor Research Holter Mode feature: 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.
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|---|---|
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Age, Continuous
|
67.0 years
STANDARD_DEVIATION 11.7 • n=61 Participants
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Sex: Female, Male
Female
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19 Participants
n=61 Participants
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Sex: Female, Male
Male
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42 Participants
n=61 Participants
|
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Race/Ethnicity, Customized
Asian Indian
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0 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
African American
|
4 Participants
n=61 Participants
|
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Race/Ethnicity, Customized
Native Hawaiian
|
0 Participants
n=61 Participants
|
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Race/Ethnicity, Customized
Japanese
|
0 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Other Pacific Islander
|
0 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
56 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Not Reportable Per Local Laws or Regulations
|
0 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Subject/Physician Chose not to Provide Information
|
0 Participants
n=61 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=61 Participants
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|
Race/Ethnicity, Customized
Hispanic or Latino
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4 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
55 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Puerto Rican
|
1 Participants
n=61 Participants
|
|
Race/Ethnicity, Customized
Subject/Physician Chose Not to Provide Information
|
0 Participants
n=61 Participants
|
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Region of Enrollment
United States
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61 Participants
n=61 Participants
|
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Number of Participants with Heart Failure
Yes
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54 Participants
n=61 Participants
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Number of Participants with Heart Failure
No
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7 Participants
n=61 Participants
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New York Heart Association Classification
Class I
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25 Participants
n=54 Participants • Includes the 54 patients who had heart failure
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New York Heart Association Classification
Class II
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29 Participants
n=54 Participants • Includes the 54 patients who had heart failure
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|
New York Heart Association Classification
Class III
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0 Participants
n=54 Participants • Includes the 54 patients who had heart failure
|
|
New York Heart Association Classification
Class IV
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0 Participants
n=54 Participants • Includes the 54 patients who had heart failure
|
|
Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration
0
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7 participants with hospitalization
n=61 Participants • Analysis included the 61 patients of which only 54 had heart failure so only 54 have NYHA,remaining 7 had no Heart failure
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Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration
1
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54 participants with hospitalization
n=61 Participants • Analysis included the 61 patients of which only 54 had heart failure so only 54 have NYHA,remaining 7 had no Heart failure
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Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration
2
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0 participants with hospitalization
n=61 Participants • Analysis included the 61 patients of which only 54 had heart failure so only 54 have NYHA,remaining 7 had no Heart failure
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Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration
3
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0 participants with hospitalization
n=61 Participants • Analysis included the 61 patients of which only 54 had heart failure so only 54 have NYHA,remaining 7 had no Heart failure
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Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration
>3
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0 participants with hospitalization
n=61 Participants • Analysis included the 61 patients of which only 54 had heart failure so only 54 have NYHA,remaining 7 had no Heart failure
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No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration
0
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7 participants with hospitalization
n=61 Participants • Analysis included 61 patients, but only 54 patients had heart failure
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No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration
1
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54 participants with hospitalization
n=61 Participants • Analysis included 61 patients, but only 54 patients had heart failure
|
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No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration
2
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0 participants with hospitalization
n=61 Participants • Analysis included 61 patients, but only 54 patients had heart failure
|
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No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration
3
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0 participants with hospitalization
n=61 Participants • Analysis included 61 patients, but only 54 patients had heart failure
|
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No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration
>3
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0 participants with hospitalization
n=61 Participants • Analysis included 61 patients, but only 54 patients had heart failure
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# participants with events with intravenous HF therapy/ultrafiltration, no hospitalization
0
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54 participants with events
n=61 Participants • Of the 61 patients Included, only 54 patients who had heart failure (HF)was included in the analysis remining 7 had no HF
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# participants with events with intravenous HF therapy/ultrafiltration, no hospitalization
1
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0 participants with events
n=61 Participants • Of the 61 patients Included, only 54 patients who had heart failure (HF)was included in the analysis remining 7 had no HF
|
|
# participants with events with intravenous HF therapy/ultrafiltration, no hospitalization
2
|
0 participants with events
n=61 Participants • Of the 61 patients Included, only 54 patients who had heart failure (HF)was included in the analysis remining 7 had no HF
|
|
# participants with events with intravenous HF therapy/ultrafiltration, no hospitalization
3
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0 participants with events
n=61 Participants • Of the 61 patients Included, only 54 patients who had heart failure (HF)was included in the analysis remining 7 had no HF
|
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# participants with events with intravenous HF therapy/ultrafiltration, no hospitalization
>3
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0 participants with events
n=61 Participants • Of the 61 patients Included, only 54 patients who had heart failure (HF)was included in the analysis remining 7 had no HF
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Left Ventricular Ejection Fraction ( LVEF)
|
42.15 percentage of ejection fraction
STANDARD_DEVIATION 13.63 • n=61 Participants
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Left ventricular end diastolic diameter
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48.3 mm
STANDARD_DEVIATION 12.76 • n=61 Participants
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LV wall thickness
|
10.26 mm
STANDARD_DEVIATION 1.98 • n=61 Participants
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PRIMARY outcome
Timeframe: During In-clinic Testing Visit, an average of 2 hoursPopulation: 15 subjects were used to generate the algorithm and not included in the primary endpoint analysis. 2 subjects did not have usable data.
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).
Outcome measures
| Measure |
All Enrolled Subjects
n=44 Participants
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.
Enabling Sensor Research Holter Mode feature: 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.
|
|---|---|
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Daily Capnography Respiration Rate
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15.3 breaths per minute
Standard Deviation 3.7
|
PRIMARY outcome
Timeframe: During In-clinic Testing Visit, an average of 2 hoursPopulation: 15 subjects were used to generate the algorithm and not included in the primary endpoint analysis. 2 subjects did not have usable data.
Daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.
Outcome measures
| Measure |
All Enrolled Subjects
n=44 Participants
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.
Enabling Sensor Research Holter Mode feature: 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.
|
|---|---|
|
Daily Device-derived Respiration Rate
|
15.5 breaths per minute
Standard Deviation 3.5
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PRIMARY outcome
Timeframe: During In-clinic Testing Visit, an average of 2 hoursPopulation: 15 subjects were used to generate the algorithm and not included in the primary endpoint analysis. 2 subjects did not have usable data.
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.
Outcome measures
| Measure |
All Enrolled Subjects
n=44 Participants
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.
Enabling Sensor Research Holter Mode feature: 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.
|
|---|---|
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Difference in Respiration Rate
|
0.2 breaths per minute
Standard Deviation 1.1
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Adverse Events
All Enrolled Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place