Status:
COMPLETED
Crome/Cobalt Respiration Study
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
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...
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. Su...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 21 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT06089694
Start Date
November 21 2023
End Date
June 12 2024
Last Update
August 15 2024
Active Locations (4)
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1
Hartford Hospital
Hartford, Connecticut, United States, 06102
2
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, United States, 56303-1900
3
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
4
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States, 78705-1852