Crome/Cobalt Respiration Study

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.

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:

• Model 6946M
• Model 6947
• Model 6947M
• Model 6935
• Model 6935M
• 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

• Subject has existing condition that necessitates the use of supplemental oxygen
• Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator
• Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
• Subject has an active or suspected lead integrity issue, in the opinion of the investigator
• Subject is enrolled in another study that could confound the results of this study
• Subject has NYHA Class IV heart failure