Heart Failure
Conditions
Brief 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).
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.
Interventions
DEVICEEnabling 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.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 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) 2. 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 * Model 6935M 3. Subject is ≥ 18 years of age 4. Subject (or subject's legally authorized representative) is willing and able to provide written informed consent 5. Subject is willing and able to comply with study procedures
Exclusion criteria
1. Subject has existing condition that necessitates the use of supplemental oxygen 2. Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator 3. Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator 4. Subject has an active or suspected lead integrity issue, in the opinion of the investigator 5. Subject is enrolled in another study that could confound the results of this study 6. Subject has NYHA Class IV heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily Capnography Respiration Rate | 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 | 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 | 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. |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 11.7 |
| Left Ventricular Ejection Fraction ( LVEF) | 42.15 percentage of ejection fraction STANDARD_DEVIATION 13.63 |
| Left ventricular end diastolic diameter | 48.3 mm STANDARD_DEVIATION 12.76 |
| LV wall thickness | 10.26 mm STANDARD_DEVIATION 1.98 |
| New York Heart Association Classification Class I | 25 Participants |
| New York Heart Association Classification Class II | 29 Participants |
| New York Heart Association Classification Class III | 0 Participants |
| New York Heart Association Classification Class IV | 0 Participants |
| No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration 0 | 7 participants with hospitalization |
| No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration 1 | 54 participants with hospitalization |
| No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration 2 | 0 participants with hospitalization |
| No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration 3 | 0 participants with hospitalization |
| No.of participants with heart failure hospitalizations with intravenous HF therapy/ultrafiltration >3 | 0 participants with hospitalization |
| Number of Participants with Heart Failure No | 7 Participants |
| Number of Participants with Heart Failure Yes | 54 Participants |
| Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration 0 | 7 participants with hospitalization |
| Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration 1 | 54 participants with hospitalization |
| Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration 2 | 0 participants with hospitalization |
| Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration 3 | 0 participants with hospitalization |
| Number of participants with heart failure hospitalization w/o heart failure therapy/ultrafiltration >3 | 0 participants with hospitalization |
| # participants with events with intravenous HF therapy/ultrafiltration, no hospitalization 0 | 54 participants with events |
| # participants with events with intravenous HF therapy/ultrafiltration, no hospitalization 1 | 0 participants with events |
| # participants with events with intravenous HF therapy/ultrafiltration, no hospitalization 2 | 0 participants with events |
| # participants with events with intravenous HF therapy/ultrafiltration, no hospitalization 3 | 0 participants with events |
| # participants with events with intravenous HF therapy/ultrafiltration, no hospitalization >3 | 0 participants with events |
| Race/Ethnicity, Customized African American | 4 Participants |
| Race/Ethnicity, Customized Asian Indian | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants |
| Race/Ethnicity, Customized Japanese | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 55 Participants |
| Race/Ethnicity, Customized Not Reportable Per Local Laws or Regulations | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Puerto Rican | 1 Participants |
| Race/Ethnicity, Customized Subject/Physician Chose not to Provide Information | 0 Participants |
| Race/Ethnicity, Customized Subject/Physician Chose Not to Provide Information | 0 Participants |
| Race/Ethnicity, Customized White or Caucasian | 56 Participants |
| Region of Enrollment United States | 61 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 0 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
None listed