Monitoring heart health in newborns with univentricular heart defects using a special device
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
EARLY_PHASE1 · Boston Children's Hospital · NCT05744934
This study is testing a special heart monitor for newborns with a specific heart condition to see if it can safely track their heart health after surgery.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | N/A to 30 Days |
| Sex | All |
| Sponsor | Boston Children's Hospital (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05744934 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility and safety of implanting a loop recorder in newborns who have undergone stage 1 palliation for univentricular heart defects. The LUX-DX™ device will be implanted during chest closure surgery to continuously monitor heart rate and detect arrhythmias during the critical interstage period. Participants will be monitored for a duration ranging from 6 months to 3 years to gather data on the device's effectiveness and safety in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are newborns with single ventricle physiology undergoing stage 1 palliation within the first month of life.
Not a fit: Patients who are premature, have low birth weight, or require devices sensitive to magnetic fields may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance monitoring and management of heart conditions in newborns, potentially improving outcomes.
How similar studies have performed: While this approach is innovative, similar studies using implantable devices for continuous monitoring in pediatric populations have shown promise.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Audrey Dionne, MD
- Email: audrey.dionne@cardio.chboston.org
- Phone: 617-355-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Univentricular Heart