Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Univentricular Heart Clinical Trial

Official title:

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05744934
• Other study ID #: IRB-P00044387
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 15, 2023
• Est. completion date: September 10, 2027

Study information

• Verified date: February 2024
• Source: Boston Children's Hospital
• Contact: Audrey Dionne, MD
• Phone: 617-355-0000
• Email: audrey.dionne[@]cardio.chboston.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this investigation is to evaluate the feasibility and safety of implantable loop recorder implantation (using the LUX-DX™) in newborns undergoing stage 1 palliation. The secondary objective of the investigation is to evaluate the feasibility of continuous measurement of heart rate and arrhythmia using an implantable loop recorder (LUX-Dx™) during the interstage period. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 10, 2027
• Est. primary completion date: September 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life

Exclusion Criteria:

• Prematurity (<36 weeks gestational age)
• 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

Related Conditions & MeSH terms

• Univentricular Heart

Intervention

Device:
• LUX-Dx™
Placement of LUX-Dx at the time of stage 1 palliation

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with successful ILR implantation at the time of surgery	Feasibility of ILR implantation	At the time of stage 1 surgery, typically the first week of life
Primary	Number of patients with ILR related complication (any of: infection, erosion, device migration, foreign body rejection phenomena, formation of hematomas or seromas, local tissue reaction and/or tissue damage	Safety of ILR implantation	Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary	Number of patient who completed >70% planned ILR transmissions		Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary	Number of patients with arrhythmias	Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds	Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary	Number of patients with interstage complication	Any complication, including unplanned emergency department visit, unscheduled hospital admission, unscheduled intensive care unit admission, arrhythmias, major interstage intervention, minor interstage intervention, cardiac arrest, death	Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary	Complications at the time of ILR removal	Defined as easily removed, removed with difficulty, removed with complication	At stage 2 or 3 palliation, typically between 4 months and 4 years of age