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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enabling Sensor Research Holter Mode feature | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Respiration Rates Comparison (Activities Representative of Nightly Average) | 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. | During In-clinic Testing Visit, an average of 2 hours |
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Inclusion Criteria:
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
Exclusion Criteria:
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hartford Hospital | Hartford | Connecticut | 06102 | United States | ||
| CentraCare Heart & Vascular Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 14, 2025 | |
| Reset | Jul 30, 2025 | |
| Release | Dec 3, 2025 | |
| Reset | Dec 17, 2025 | |
| Release | Feb 26, 2026 | |
| Reset | Feb 26, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 14, 2025 | Jul 30, 2025 | |||
| Dec 3, 2025 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Saint Cloud |
| Minnesota |
| 56303-1900 |
| United States |
| South Oklahoma Heart Research | Oklahoma City | Oklahoma | 73135 | United States |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705-1852 | United States |
| Dec 17, 2025 |
| Feb 26, 2026 | Feb 26, 2026 |