Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
NCT ID: NCT05744934
Last Updated: 2024-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
10 participants
INTERVENTIONAL
2023-03-15
2027-09-10
Brief Summary
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An implantable loop recorder will be placed at the time of chest closure following stage 1 palliation (either at the time of index surgery or delayed). The device will be placed in a subclavicular pouch through the existing sternotomy incision. Participants will be in the study for 6 months to 3 years.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Interventions
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LUX-Dx™
Placement of LUX-Dx at the time of stage 1 palliation
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Birth weight \<2.5 kg
* Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)
* Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.
* Clinical team does not think that the patient is a good candidate
30 Days
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Audrey Dionne
Principal Investigator
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Audrey Dionne, MD
Role: primary
Other Identifiers
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IRB-P00044387
Identifier Type: -
Identifier Source: org_study_id
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