RECRUITING

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Interstage Monitoring Using an Implantable Loop Recorder: A Pilot Study

Quick Facts

Study Start:2023-03-15
Study Completion:2027-09-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05744934

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 30 Days
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients with single ventricle physiology undergoing stage 1 palliation in the 1st month of life
  1. * Prematurity (\<36 weeks gestational age)
  2. * Birth weight \<2.5 kg
  3. * Hybrid stage 1 palliation (patent ductus arteriosus stenting, bilateral pulmonary artery bands)
  4. * Presence and/or need for devices sensitive to magnetic fields such as hearing aids, pacemaker, and other implanted devices.
  5. * Clinical team does not think that the patient is a good candidate

Contacts and Locations

Study Contact

Audrey Dionne, MD
CONTACT
617-355-0000
audrey.dionne@cardio.chboston.org
Olivia Rossi
CONTACT
olivia.rossi@cardio.chboston.org

Study Locations (Sites)

Boston Children's Hospital
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-15
Study Completion Date2027-09-10

Study Record Updates

Study Start Date2023-03-15
Study Completion Date2027-09-10

Terms related to this study

Additional Relevant MeSH Terms

  • Univentricular Heart