Univentricular HeartEarly Phase 1NCT05744934
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
A Early Phase 1 study testing LUX-Dx™ in people with Univentricular Heart, run by Boston Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 30 days
- Conditions the study is for
- Univentricular Heart
- What is being tested?
- LUX-Dx™
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 30 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
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.
- Conditions
- Univentricular Heart
- Being tested
- LUX-Dx™
- Medical subject headings
- Univentricular Heart
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUX-Dx™Device
Placement of LUX-Dx at the time of stage 1 palliation
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful ILR implantation at the time of surgery
Feasibility of ILR implantation
Measured: At the time of stage 1 surgery, typically the first week of life
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
Measured: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Secondary outcomes (4)
Number of patient who completed >70% planned ILR transmissions
Measured: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Number of patients with arrhythmias
Any arrhythmia, including supraventricular tachycardia, junctional ectopic tachycardia, ventricular tachycardia, atrioventricular block, pause >2.5 seconds
Measured: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
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
Measured: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Complications at the time of ILR removal
Defined as easily removed, removed with difficulty, removed with complication
Measured: At stage 2 or 3 palliation, typically between 4 months and 4 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start15 Mar 2023
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Univentricular HeartStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Audrey Dionne, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05744934
- Sponsor's protocol ID
- IRB-P00044387
- Status last verified
- May 2026
- First submitted
- 3 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT05744934
- Acronym / sponsor ID
- IRB-P00044387
- Conditions
- Univentricular Heart
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LUX-Dx™Placement of LUX-Dx at the time of stage 1 palliation | Device | – |
Primary outcome
Number of patients with successful ILR implantation at the time of surgery
Time frame: At the time of stage 1 surgery, typically the first week of life
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
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Safety of ILR implantation
4 secondary outcomes
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
Number of patients with arrhythmias
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Number of patients with interstage complication
Time frame: Between the stage 1 and stage 2 surgery, typically until 4-6 months of age
Complications at the time of ILR removal
Time frame: At stage 2 or 3 palliation, typically between 4 months and 4 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LUX-Dx™ in people with Univentricular Heart, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful ILR implantation at the time of surgery (time frame: At the time of stage 1 surgery, typically the first week of life). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.