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Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Primary Purpose

Univentricular Heart

Status
Not yet recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
LUX-Dx™
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Univentricular Heart

Eligibility Criteria

undefined - 30 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boston Children's Hospital

Outcomes

Primary Outcome Measures

Number of patients with successful ILR implantation at the time of surgery
Feasibility of ILR implantation
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

Secondary Outcome Measures

Number of patient who completed >70% planned ILR transmissions
Number of patients with arrhythmias
Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds
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
Complications at the time of ILR removal
Defined as easily removed, removed with difficulty, removed with complication

Full Information

First Posted
February 3, 2023
Last Updated
June 12, 2023
Sponsor
Boston Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05744934
Brief Title
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Official Title
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
September 10, 2024 (Anticipated)
Study Completion Date
September 10, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Univentricular Heart

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
LUX-Dx™
Intervention Description
Placement of LUX-Dx at the time of stage 1 palliation
Primary Outcome Measure Information:
Title
Number of patients with successful ILR implantation at the time of surgery
Description
Feasibility of ILR implantation
Time Frame
At the time of stage 1 surgery, typically the first week of life
Title
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
Description
Safety of ILR implantation
Time Frame
Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary Outcome Measure Information:
Title
Number of patient who completed >70% planned ILR transmissions
Time Frame
Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Title
Number of patients with arrhythmias
Description
Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds
Time Frame
Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Title
Number of patients with interstage complication
Description
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
Time Frame
Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Title
Complications at the time of ILR removal
Description
Defined as easily removed, removed with difficulty, removed with complication
Time Frame
At stage 2 or 3 palliation, typically between 4 months and 4 years of age

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Dionne, MD
Phone
617-355-0000
Email
audrey.dionne@cardio.chboston.org
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia Rossi
Email
olivia.rossi@cardio.chboston.org
Facility Information:
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

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