Crome/Cobalt Respiration Study

Completed

Conditions studied: Heart Failure

In brief

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).

Key facts

Study ID

NCT06089694

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

61

Starts

2023-11-21

Expected to finish

2024-06-12

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hartford Hospital — Hartford, Connecticut, United States
• CentraCare Heart & Vascular Center — Saint Cloud, Minnesota, United States
• South Oklahoma Heart Research — Oklahoma City, Oklahoma, United States
• Texas Cardiac Arrhythmia Research Foundation — Austin, Texas, United States

Full record on ClinicalTrials.gov

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