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Congenital Heart Disease

5
Pipeline Programs
23
Companies
27
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
1
1
1
0
Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

19 companies ranked by most advanced pipeline stage

Applied Medical
Applied MedicalCA - Rancho Santa Margarita
1 program
1
Empagliflozin 10 mgPhase 3
Angeles Therapeutics
Angeles TherapeuticsCA - Los Angeles
4 programs
1
Closed loop stimulationPhase 2/3
BosentanN/A1 trial
Parent Navigator ProgramN/A1 trial
RemodulinN/A1 trial
Active Trials
NCT00989911Completed10Est. Mar 2013
NCT07023367Recruiting40Est. Jun 2026
NCT01980979Withdrawn0Est. Dec 2015
Oregon Therapeutics
Oregon TherapeuticsFrance - Paris
3 programs
1
Spironolactone 25mgPhase 21 trial
Diffuse Myocardial Fibrosis in Fontan PatientsN/A1 trial
Use of the CHD appN/A1 trial
Active Trials
NCT01929174Completed18Est. Mar 2019
NCT04463446Completed207Est. Dec 2025
NCT01069510Completed40Est. Mar 2017
Human BioSciences
Human BioSciencesWV - Martinsburg
5 programs
1
ErythropoetinPhase 1/21 trial
DigoxinN/A1 trial
Genetic Analysis of Left-Right Axis FormationsN/A1 trial
SpO2 and PIx MeasurementN/A1 trial
The Genetic Basis of Congenital Heart Disease in AfricaN/A1 trial
Active Trials
NCT03877965Completed50Est. Jan 2022
NCT00341133Completed900
NCT04056104Completed543Est. Dec 2021
+2 more trials
Chiesi
ChiesiBrazil - Santana de Parnaíba
1 program
1
CurosurfPhase 11 trial
Active Trials
NCT04181255Terminated2Est. Jun 2020
Medtronic
MedtronicNJ - Phillipsburg
3 programs
Harmony TPV SystemN/A1 trial
Harmony TPV SystemN/A1 trial
Native Outflow Tract TPVN/A1 trial
Active Trials
NCT05077774Active Not Recruiting150Est. Mar 2035
NCT02979587Active Not Recruiting86Est. Feb 2031
NCT01762124Completed20Est. Jul 2020
Genome & Company
Genome & CompanyKorea - Suwon
2 programs
Genetic Analysis of Left-Right Axis FormationsN/A
The Genetic Basis of Congenital Heart Disease in AfricaN/A
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
2 programs
Sacubitril 49 MG / Valsartan 51 MG [Entresto] BIDPHASE_2_31 trial
Empagliflozin 10 mgPHASE_31 trial
Active Trials
NCT05580510Unknown160Est. Mar 2024
NCT06955260Not Yet Recruiting410Est. Mar 2028
Autus Valve
Autus ValveMA - Boston
1 program
Autus ValveN/A2 trials
Active Trials
NCT07466745Not Yet Recruiting36Est. Apr 2036
NCT05006404Active Not Recruiting51Est. Feb 2036
Xeltis
XeltisNetherlands - Eindhoven
1 program
Bioabsorbable Pulmonary Valved ConduitN/A1 trial
Active Trials
NCT02700100Unknown12Est. Apr 2022
Alder Therapeutics
Alder TherapeuticsSweden - Solna
1 program
Calprotectin and Gut Disease StudyN/A1 trial
Active Trials
NCT07112794Not Yet Recruiting300Est. Dec 2027
Starlight Therapeutics
1 program
Ductus Arteriosus StentN/A
Starlight Cardiovascular
1 program
Ductus Arteriosus StentN/A1 trial
Active Trials
NCT07114718Recruiting35Est. Apr 2028
Nonin
NoninMN - Plymouth
1 program
EQUANOX Advance 8004CB sensorN/A1 trial
Active Trials
NCT01849120Completed35Est. Sep 2015
United Therapeutics
United TherapeuticsMD - Silver Spring
1 program
RemodulinN/A
Pediatrix Therapeutics
Pediatrix TherapeuticsChina - Shanghai
1 program
The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart DiseaseN/A1 trial
Active Trials
NCT01749059Completed6,147Est. Oct 2016
Eppendorf
EppendorfGermany - Hamburg
1 program
The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)N/A1 trial
Active Trials
NCT04848844Recruiting2,000Est. Jul 2030
Innovation Pharmaceuticals
1 program
VITLS DeviceN/A1 trial
Active Trials
NCT05526768Completed27Est. May 2023
Biotronik
BiotronikGermany - Berlin
1 program
Closed loop stimulationPHASE_2_31 trial
Active Trials
NCT03361189Terminated4Est. Nov 2021

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Boehringer IngelheimEmpagliflozin 10 mg
Boehringer IngelheimSacubitril 49 MG / Valsartan 51 MG [Entresto] BID
BiotronikClosed loop stimulation
Oregon TherapeuticsSpironolactone 25mg
Human BioSciencesErythropoetin
ChiesiCurosurf
Autus ValveAutus Valve
Starlight CardiovascularDuctus Arteriosus Stent
Alder TherapeuticsCalprotectin and Gut Disease Study
Angeles TherapeuticsParent Navigator Program
Autus ValveAutus Valve
Innovation PharmaceuticalsVITLS Device
Oregon TherapeuticsUse of the CHD app
MedtronicHarmony TPV System
EppendorfThe PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)

Showing 15 of 27 trials with date data

Clinical Trials (27)

Total enrollment: 12,578 patients across 27 trials

SGLT2 Inhibition With Empagliflozin in Fontan Circulatory Failure

Start: May 2025Est. completion: Mar 2028410 patients
Phase 3Not Yet Recruiting
NCT05580510Boehringer IngelheimSacubitril 49 MG / Valsartan 51 MG [Entresto] BID

" Evaluation of Safety and Efficacy of Empagliflozin and Sacubitril/Valsartan for CHF With Reduced Ejection Fraction in ACHD "

Start: Feb 2023Est. completion: Mar 2024160 patients
Phase 2/3Unknown
NCT03361189BiotronikClosed loop stimulation

Specialized Pacing for Patients With Congenital Heart Disease

Start: May 2021Est. completion: Nov 20214 patients
Phase 2/3Terminated

Spironolactone in Adult Congenital Heart Disease

Start: Feb 2010Est. completion: Mar 201740 patients
Phase 2Completed

Erythropoetin Neuroprotection for Neonatal Cardiac Surgery

Start: Sep 2006Est. completion: Sep 201562 patients
Phase 1/2Completed

Cold Heart Study: A Randomized Pilot Trial of Surfactant Therapy

Start: Feb 2020Est. completion: Jun 20202 patients
Phase 1Terminated

Autus Valve Continued Access Study (CAS)

Start: Apr 2026Est. completion: Apr 203636 patients
N/ANot Yet Recruiting

Starlight Cardiovascular Lifeline Ductus Arteriosus Stent IDE Study

Start: Dec 2025Est. completion: Apr 202835 patients
N/ARecruiting
NCT07112794Alder TherapeuticsCalprotectin and Gut Disease Study

Calprotectin and Gut Disease Study

Start: Nov 2025Est. completion: Dec 2027300 patients
N/ANot Yet Recruiting
NCT07023367Angeles TherapeuticsParent Navigator Program

Parent Navigator Program (PNP) to Improve Outcomes in Latino/x Children and Parents

Start: Oct 2025Est. completion: Jun 202640 patients
N/ARecruiting

Autus Valve Pivotal Study

Start: Feb 2024Est. completion: Feb 203651 patients
N/AActive Not Recruiting

Evaluation of VITLS Compared to Traditional Inpatient Monitoring in Cardiac Shunt-Dependent Children

Start: Oct 2022Est. completion: May 202327 patients
N/ACompleted

The Impact of an Innovative eHealth Transition Intervention on Self-Management Skills Among Young Adults With Congenital Heart Disease

Start: Jan 2022Est. completion: Dec 2025207 patients
N/ACompleted
NCT05077774MedtronicHarmony TPV System

Harmony TPV Post-Approval Study

Start: Oct 2021Est. completion: Mar 2035150 patients
N/AActive Not Recruiting
NCT04848844EppendorfThe PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)

The PAtients pResenTing With COngenital HeaRt DIseAse Register (ARTORIA-R)

Start: Sep 2020Est. completion: Jul 20302,000 patients
N/ARecruiting
NCT04056104Human BioSciencesSpO2 and PIx Measurement

Improving Critical Congenital Heart Disease Screening With Addition of Perfusion Measurements

Start: Oct 2019Est. completion: Dec 2021543 patients
N/ACompleted

Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease

Start: Aug 2019Est. completion: Jan 202250 patients
N/ACompleted
NCT02979587MedtronicHarmony TPV System

The Medtronic Harmony™ Transcatheter Pulmonary Valve Clinical Study

Start: Jan 2017Est. completion: Feb 203186 patients
N/AActive Not Recruiting
NCT02700100XeltisBioabsorbable Pulmonary Valved Conduit

Study to Assess Safety of the Pulmonary Valved Conduit (PV-001) in Subjects Undergoing Right Ventricular Outflow Tract Reconstruction

Start: Jun 2016Est. completion: Apr 202212 patients
N/AUnknown

Efficacy of Remodulin in Adults With Congenital Heart Disease (ACHD) and Pulmonary Hypertension

Start: Nov 2013Est. completion: Dec 20150
N/AWithdrawn
NCT01952171Human BioSciencesThe Genetic Basis of Congenital Heart Disease in Africa

The Genetic Basis of Congenital Heart Disease in Africa

Start: Sep 20131,233 patients
N/ACompleted
NCT01929174Oregon TherapeuticsDiffuse Myocardial Fibrosis in Fontan Patients

Diffuse Myocardial Fibrosis in Fontan Patients

Start: Aug 2013Est. completion: Mar 201918 patients
N/ACompleted
NCT01849120NoninEQUANOX Advance 8004CB sensor

NIRS Predict Low Cardiac Output State in Neonates and Infants in Cardiac Surgery

Start: May 2013Est. completion: Sep 201535 patients
N/ACompleted
NCT01762124MedtronicNative Outflow Tract TPV

Study of the Native Outflow Tract Transcatheter Pulmonary Valve (TPV)

Start: Oct 2012Est. completion: Jul 202020 patients
N/ACompleted
NCT01749059Pediatrix TherapeuticsThe Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

The Impact of Implementing a Universal Newborn Screening for Critical Congenital Heart Disease

Start: Jun 2012Est. completion: Oct 20166,147 patients
N/ACompleted

Endothelin Blockade in Patients With Single Ventricle Physiology

Start: May 2010Est. completion: Mar 201310 patients
N/ACompleted
NCT00341133Human BioSciencesGenetic Analysis of Left-Right Axis Formations

Genetic Analysis of Left-Right Axis Formations

Start: Dec 1999900 patients
N/ACompleted

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
3 actively recruiting trials targeting 12,578 patients
23 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.