Crome/Cobalt Respiration Study
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Device: 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.
|
Outcome Measures
Primary Outcome Measures
- Respiration Rates Comparison (Activities Representative of Nightly Average) [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.
Eligibility Criteria
Criteria
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)
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Subject is implanted with one of the following models of a true bipolar right ventricular lead manufactured by Medtronic:
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Model 6946M
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Model 6947
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Model 6947M
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Model 6935
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Model 6935M
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Subject is ≥ 18 years of age
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Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
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Subject is willing and able to comply with study procedures
Exclusion Criteria:
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Subject has existing condition that necessitates the use of supplemental oxygen
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Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator
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Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
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Subject has an active or suspected lead integrity issue, in the opinion of the investigator
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Subject is enrolled in another study that could confound the results of this study
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Subject has NYHA Class IV heart failure
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MDT22030