Crome/Cobalt Respiration Study

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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Device: Enabling Sensor Research Holter Mode feature

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. 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.

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital
  • Minnesota
    • Saint Cloud, Minnesota, United States, 56303-1900
      • CentraCare Heart & Vascular Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73135
      • South Oklahoma Heart Research
  • Texas
    • Austin, Texas, United States, 78705-1852
      • Texas Cardiac Arrhythmia Research Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population for this study will include adult subjects who are ≥18 years of age, who have an active, implanted Crome or Cobalt ICD or CRT-D system that's been implanted for at least 30 days and which has not yet reached the Recommended Replacement Time (RRT), and who do not have any contraindications that would impact their ability to complete the required breathing and exercise activities, which aligns with the key eligibility criteria for the study. A minimum of 30% of all enrolled subjects will have a documented history of heart failure and a minimum of 20% of all enrolled subjects will be female (as identified at birth).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All Enrolled Subjects; In-clinic Testing Visit: All enrolled subjects will have a Holter recorder, capnography monitor and SpO2 sensor applied and will undergo various breathing/exercise activities. Subjects will go home connected to the Holter recorder for 24 hours for collection of ambulatory data.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Actual): June 12, 2024
• Study Completion (Actual): June 12, 2024

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: MDT22030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No