Crome/Cobalt Respiration Study

NCT ID: NCT06089694

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-21
• Study Completion Date: 2024-06-12

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.

Conditions

Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Enabling Sensor Research Holter Mode feature

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hartford Hospital

Hartford, Connecticut, United States

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, United States

South Oklahoma Heart Research

Oklahoma City, Oklahoma, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Countries

United States

Other Identifiers

MDT22030

Identifier Type: -

Identifier Source: org_study_id