Crome/Cobalt Respiration Study

Heart Failure Clinical Trial

Official title:

Crome/Cobalt Respiration Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06089694
• Other study ID #: MDT22030
• Status: Completed
• Start date: November 21, 2023
• Est. completion date: June 12, 2024

Study information

• Verified date: June 2024
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 using a Holter recorder).

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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 12, 2024
• Est. primary completion date: June 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

6. Subject has NYHA Class IV heart failure

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Enabling Sensor Research Holter Mode feature
The Sensor Research Holter Mode feature within the Crome and Cobalt ICD and CRT-D devices will be enabled for a short period of time at the In-clinic Testing Visit to allow for desired data collection.

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Hartford Hospital	Hartford	Connecticut
United States	South Oklahoma Heart Research	Oklahoma City	Oklahoma
United States	CentraCare Heart & Vascular Center	Saint Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiration Rates Comparison (Activities Representative of Nightly Average)	Difference between the daily respiration rate determined using capnography and the daily respiration rate determined by the Crome and Cobalt ICD and CRT-D devices.	During In-clinic Testing Visit, an average of 2 hours