Crome/Cobalt Respiration Study

Completed

• Conditions: Heart Failure
• Interventions: Device: Enabling Sensor Research Holter Mode feature

• Registration Number: NCT06089694
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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 using a Holter recorder).

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 Timeline

• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-13
• Study First Posted: 2023-10-18
• Study Start: 2023-11-21
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
All Enrolled Subjects	Enabling Sensor Research Holter Mode feature	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.

Primary Outcome Measures

Name	Time	Method
Respiration Rates Comparison (Activities Representative of Nightly Average)	During In-clinic Testing Visit, an average of 2 hours	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.

Trial Locations

Locations (4)

Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

CentraCare Heart & Vascular Center; 🇺🇸 Saint Cloud, Minnesota, United States

Texas Cardiac Arrhythmia Research Foundation; 🇺🇸 Austin, Texas, United States

South Oklahoma Heart Research; 🇺🇸 Oklahoma City, Oklahoma, United States