NCT06089694Completed
Crome/Cobalt Respiration Study
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 61 (actual)
- First submitted
- 9 Oct 2023
- Start date
- 21 Nov 2023
- Primary completion date
- 12 Jun 2024
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Diseases
- Heart failure
- NCT number
- NCT06089694
What you commit to
- Study type: Observational
- Participants enrolled: 61
- From 21 Nov 2023 to the primary completion date, 12 Jun 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
Other illness
- 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
- Subject has NYHA Class IV heart failure
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Cardiac Arrhythmia Research Foundation Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| South Oklahoma Heart Research Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| CentraCare Heart & Vascular Center Coordinator of this site? Confirm its status | Saint Cloud | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.