NCT06089694

Crome/Cobalt Respiration Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 61 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heart Failure

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-21
• Primary completion: 2024-06-12
• Completion: 2024-06-12
• First posted: 2023-10-18
• Last updated: 2024-08-15

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study