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NCT05744934 · ClinicalTrials.gov registry record · Early Phase 1
Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study
A Early Phase 1 study of Univentricular Heart, sponsored by Boston Children's Hospital.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT05744934 is a Early Phase 1 study of Univentricular Heart that is actively recruiting participants, run by Boston Children's Hospital. The registered enrollment target is 10 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05744934, a Early Phase 1 study of Univentricular Heart, is actively recruiting participants, sponsored by Boston Children's Hospital.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DEVICE LUX-Dx™
Study Locations (1)
Massachusetts
- Boston Children's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2023-03-15 |
| Est. Completion | 2027-09-10 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05744934
The ClinicalTrials.gov registry entry for NCT05744934 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Univentricular Heart appearing as the primary indexed condition, and to 1 intervention - of which LUX-Dx™ is the first listed.
NCT05744934 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05744934 about?
NCT05744934 is a clinical study titled "Interstage Monitoring Using an Implantable Loop Recorder: A Pilot 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 hear...
What is the current status of trial NCT05744934?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2023-03-15. Estimated completion is 2027-09-10.
What conditions does trial NCT05744934 study?
This clinical trial studies the following conditions: Univentricular Heart.
What interventions are being tested in trial NCT05744934?
The interventions under investigation include: LUX-Dx™ (DEVICE).
Who is sponsoring clinical trial NCT05744934?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05744934 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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