Crome/Cobalt Respiration Study

Last updated: August 14, 2024
Sponsor: Medtronic Cardiac Rhythm and Heart Failure
Overall Status: Completed

Phase

N/A

Condition

Hyponatremia

Chest Pain

Congestive Heart Failure

Treatment

Enabling Sensor Research Holter Mode feature

Clinical Study ID

NCT06089694
MDT22030
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Subject has an active CromeTM or CobaltTM ICD or CRT-D MRI SureScanTM system whichhas been implanted for at least 30 days and which has not yet reached theRecommended Replacement Time (RRT)

  2. Subject is implanted with one of the following models of a true bipolar rightventricular lead manufactured by Medtronic:

  • Model 6946M

  • Model 6947

  • Model 6947M

  • Model 6935

  • Model 6935M

  1. Subject is ≥ 18 years of age

  2. Subject (or subject's legally authorized representative) is willing and able toprovide written informed consent

  3. Subject is willing and able to comply with study procedures

Exclusion

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 mayaffect ability to perform breathing or exercise activities, as assessed by theinvestigator

  3. Any concomitant condition that might endanger the subject through participation inthe 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 theinvestigator

  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

Total Participants: 61
Treatment Group(s): 1
Primary Treatment: Enabling Sensor Research Holter Mode feature
Phase:
Study Start date:
November 21, 2023
Estimated Completion Date:
June 12, 2024

Study 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.

Connect with a study center

  • Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • CentraCare Heart & Vascular Center

    Saint Cloud, Minnesota 56303-1900
    United States

    Site Not Available

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Texas Cardiac Arrhythmia Research Foundation

    Austin, Texas 78705-1852
    United States

    Site Not Available

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