Condition (MeSH)
Tetralogy of Fallot
ClinicalTrials.gov lists 90 trials for Tetralogy of Fallot or a narrower condition beneath it. Edwards Lifesciences has the most among industry and government lead sponsors, with 4.
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Trials per phase (log scale)
90 of the 90 trials are tagged with Tetralogy of Fallot itself; the rest are tagged with a narrower condition beneath it.
When did Tetralogy of Fallot trials start? (24)
Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.
Trials over time, by phase
- Phase 1
- Phase 1/2
- Phase 2
- Phase 2/3
- Phase 3
- Phase 4
- Not applicable
- Observational
Top of scale: 9
Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.
| Year | Trials started |
|---|---|
| 2026 (partial year) | 6 |
| 2025 | 3 |
| 2024 | 2 |
| 2023 | 5 |
| 2022 | 9 |
| 2021 | 5 |
| 2020 | 5 |
| 2019 | 4 |
| 2018 | 6 |
| 2017 | 7 |
Showing 10 of 24 earlier years.
Forecast of the full-year count, planned starts included, not rows of this table: about 6 trials starting in 2026 and about 4 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored. The 2026 forecast is below the 6 already registered with a 2026 start date: at the cutoff, 1 trials were already registered to start in October to December, more than the method's monthly average allows for, and the method does not use those planned starts.
Prediction, not a registry value: median of 36 months from start to primary completion across 6 trials still running at the 2026-10-09 snapshot; registered median of 31 months across 49 trials with a primary completion typed Actual. Source: ClinicalTrials.gov / AACT (CTTI), public domain.
What phase are Tetralogy of Fallot trials in? (8)
Shown in this order: phase order.
Show the trials by phase as a table
| Phase | Trials |
|---|---|
| Phase 1 | 5 |
| Phase 1/2 | 1 |
| Phase 2 | 2 |
| Phase 2/3 | 2 |
| Phase 3 | 1 |
| Phase 4 | 2 |
| Not applicable | 37 |
| Observational | 40 |
How many Tetralogy of Fallot trials are recruiting? (8)
Shown in this order: the order a trial moves through, from not yet recruiting to unknown.
| Status | Trials |
|---|---|
| Not yet recruiting | 4 |
| Recruiting | 18 |
| Active, not recruiting | 8 |
| Completed | 38 |
| Suspended | 1 |
Showing 5 of 8 statuses.
Status as registered on ClinicalTrials.gov. Each trial is counted once.
Which lead sponsors run the most Tetralogy of Fallot trials? (4)
Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.
| Sponsor | Trials |
|---|---|
| Edwards Lifesciences | 4 |
| Competence Network for Congenital Heart Defects | 3 |
| Medtronic Heart Valves | 2 |
| Taewoong Medical Co., Ltd. | 2 |
Which drugs are being tested for Tetralogy of Fallot? (1)
Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.
| Drug | Trials |
|---|---|
| DEXMEDETOMIDINE | 3 |
Interventions as named in the registry (14)
Shown in this order: most trials first.
| Drug | Trials |
|---|---|
| Double distilled water | 1 |
| Calcium Chloride/Calcium Gluconate | 1 |
| Recombinant Human Brain Natriuretic Peptide | 1 |
| Fluid administration | 1 |
| Low dose losartan | 1 |
Showing 5 of 14 interventions.
These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.
Which serious adverse events do Tetralogy of Fallot trials report? (10)
Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.
| Adverse event | Subjects affected | Trials |
|---|---|---|
| Cardiopulmonary insufficiency requiring ECMO | 4 | 1 |
| Tricuspid valve incompetence | 4 | 1 |
| Cardiac arrest requiring CPR and medications | 3 | 1 |
| Seizures | 3 | 1 |
| Atrial ectopy | 2 | 1 |
Showing 5 of 10 adverse events.
Which publications cover Tetralogy of Fallot? (137)
Shown in this order: major-topic papers first, then newest, then most linked to trials.
| Publication | Journal | Year | Major topic |
|---|---|---|---|
| Rapid ventricular tachycardia in patients with tetralogy of Fallot and implantable cardioverter-defibrillator: Insights from the DAI-T4F nationwide registry. | Heart rhythm | 2023 | Yes |
| The American Association for Thoracic Surgery (AATS) 2022 Expert Consensus Document: Management of infants and neonates with tetralogy of Fallot. | The Journal of thoracic and cardiovascular surgery | 2023 | Yes |
| Systematic Electrophysiological Study Prior to Pulmonary Valve Replacement in Tetralogy of Fallot: A Prospective Multicenter Study. | Circulation. Arrhythmia and electrophysiology | 2023 | Yes |
| Ten-year follow-up of dilatation of aortic structures in Fallot-type anomalies. | Pediatric cardiology | 2023 | Yes |
| Predicting Survival in Repaired Tetralogy of Fallot: A Lesion-Specific and Personalized Approach. | JACC. Cardiovascular imaging | 2022 | Yes |
Showing 5 of 137 publications.
Prevalence (75)
Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.
| Orphanet disease | Type | Class | Geography | Jurisdiction | Mapping relation |
|---|---|---|---|---|---|
| Tetralogy of Fallot | Prevalence at birth | 1-5 / 10 000 | United Kingdom | GB | Unspecified |
| Tetralogy of Fallot | Prevalence at birth | 1-5 / 10 000 | United Kingdom | GB | Exact |
| Tetralogy of Fallot | Prevalence at birth | 1-5 / 10 000 | United Kingdom | GB | Exact |
| Tetralogy of Fallot | Prevalence at birth | 1-5 / 10 000 | United States | US | Unspecified |
| Tetralogy of Fallot | Prevalence at birth | 1-5 / 10 000 | United States | US | Exact |
Showing 5 of 75 prevalence observations.
Rare-disease identity (2)
Shown in this order: exact, broader, narrower, other.
| Orphanet disease | ORPHA code | Relation | Source |
|---|---|---|---|
| Tetralogy of Fallot | 3303 | Exact | Orphanet Rare Disease Ontology (ORDO) |
| Tetralogy of Fallot | 3303 | Exact | Orphadata Science knowledge files, Product 1 |
Not on this page
Not measured: delivery record.
Checked, with nothing recorded for this condition: sub-conditions in mesh.