An observational study in Congenital Heart Disease and Single-ventricle, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 10 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by Boston Children's Hospital · Observational
Among 37 studies in Heart Defects, Congenital by Boston Children's Hospital — 9 open to participants now, 10 under way, none of them phase 3. Heart Defects, Congenital · Boston Children's Hospital.
Among the 37 studies in Heart Defects, Congenital by Boston Children's Hospital, this one is the 5th largest by enrollment of the 19 observational ones that give a count, is the only one that started in 2018, is one of 19 observational ones, and was the 18th registered.
991 studies on the registry are indexed under Heart Defects, Congenital; 251 are open to participants now.
Browse Heart Defects, Congenital studies →9 of the 37 studies in Heart Defects, Congenital by Boston Children's Hospital are open now, in 1 country. Recruiting first, the newest first:
Boston Children's Hospital · Sites in United States
Ages 1 days–12 yrs
Boston Children's Hospital · Sites in United States
Ages 1 days–7 days
Boston Children's Hospital · Sites in United States
Ages 3 mo–18 yrs
Boston Children's Hospital · Sites in United States
Ages 24–35 · Healthy volunteers
Boston Children's Hospital · Sites in United States
By country, each count listing its studies:
Of the 154 Heart Defects, Congenital studies recruiting now, 67 (44%) set no upper age limit and 79 (51%) stop at 75 or younger; 110 take children under 18; 25 take healthy volunteers.
This study: 10 Years to 60 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
37 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 2 · Phase 3 2 · Phase 4 1
First in 1988; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 146 is above the median of 119 across 440 observational studies indexed under Heart Defects, Congenital.
Median enrollment 37 across the 18 interventional studies, 64 across the 19 observational. Of the 24 that completed or were terminated, 4 (17%) have results posted.
This tab as a report to print or save as PDF → With an account.
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
7 of the studies in Heart Defects, Congenital by Boston Children's Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05687292Boston Children's HospitalApplication of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children | 2026-11-18 |
| NCT04299828Boston Children's HospitalEvaluation of Pro-Inflammatory Leukocyte Activity in Patients Undergoing Cardiac Surgery | 2026-12 |
| NCT06642662Boston Children's HospitalPrecision Medicine in the CICU: Identifying Proteomic Biomarkers | 2026-12-01 |
| NCT06434207Boston Children's HospitalExtracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis | 2026-12-01 |
| NCT06899971Boston Children's HospitalThe Association Between Tau & GFAP and Postoperative Neurological Impairment in Patients Undergoing Cardiac Surgery | 2026-12-31 |
Add all 7 to your calendar (.ics) → With an account.
Among the 37 studies in Heart Defects, Congenital by Boston Children's Hospital, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study aims to determine what are some of the clinical characteristics and associations of Fontan patients who are doing well, as well as how accurate cardiology providers are at predicting the likelihood of future adverse event in their Fontan patients.
This is a multi-center prospective study that involves collecting data from patients as well as their cardiology providers in order to determine whether there is correlation between patient-reported quality of life assessments and clinician-identified assessments of their patients. The study also involves collecting data from the medical records of participating patients and entering it into our study database.
Patients with congenital heart disease who have undergone the Fontan procedure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Participants ages 10 to 18 who have had Lateral Tunnel or Extracardiac Fontan procedures.
Participants ages 18 to 60 who have had Lateral Tunnel or Extracardiac Fontan procedures.
Surprise question
The ability of the cardiologist's response to the "surprise" question to predict adverse cardiac events within 1 year
Time frame: 1 year
Clinical characteristics and associations of the "good Fontan"
Clinical characteristics and associations of this group (the "good Fontan") are different compared to those that are in the "at-risk" category (all others that do not fit into the "good Fontan" category). Data measurements will include relevant clinical data available for each patient, including but not limited to data from cardiac surgeries, catheterizations, MRIs, echocardiograms, exercise stress tests, current medications, labs, and patient responses to questionnaires.
Time frame: 1 year
Correlation between patient and provider assessments
There will be a positive correlation of the patient's own assessment of quality of life with the clinician-identified designation of a "good Fontan."
Time frame: 1 year
Clinician factors associated with adverse events conversation with patients
Clinician factors (years of experience, primary subspecialty, gender, parenthood) are associated with beliefs in regard to appropriate timing to discuss potential long-term adverse events to Fontan patients.
Time frame: 1 year
Plan to share: No
Ran from Mar 2018 to primary completion in Mar 2023, 60 months.
Of 178 non-industry observational studies under Heart Defects, Congenital, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 83. This study's 60 months is above that.
Counting every sponsor, half of 185 studies reached it within 44 months; a quarter within 17 and three quarters within 83.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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