Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Medtronic Cardiac Rhythm and Heart Failure
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
