Crome/Cobalt Respiration Study

NCT06089694 | Completed FDA Device

• 1 other identifier: MDT22030
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 4

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).

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

Enabling Sensor Research Holter Mode feature 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.

All Enrolled Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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)
• 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
• Subject is ≥ 18 years of age
• Subject (or subject's legally authorized representative) is willing and able to provide written informed consent
• Subject is willing and able to comply with study procedures

You may not qualify if:

• Subject has existing condition that necessitates the use of supplemental oxygen
• Subject has active acute respiratory infection or respiratory disorder that may affect ability to perform breathing or exercise activities, as assessed by the investigator
• Any concomitant condition that might endanger the subject through participation in the study or interfere with study procedures, as assessed by the investigator
• Subject has an active or suspected lead integrity issue, in the opinion of the investigator
• Subject is enrolled in another study that could confound the results of this study
• Subject has NYHA Class IV heart failure

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (4)

Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

CentraCare Heart & Vascular Center

Saint Cloud, Minnesota, 56303-1900, United States

Location

South Oklahoma Heart Research

Oklahoma City, Oklahoma, 73135, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705-1852, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 18, 2023
• Study Start: November 21, 2023
• Primary Completion: June 12, 2024
• Study Completion: June 12, 2024
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)