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Completed
NCT06089694
Crome/Cobalt Respiration Study
Conditions: Heart Failure
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 61
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Location: Hartford Hospital Hartford Connecticut
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).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06089694). StuddyBuddy aggregates publicly available trial information.