UCLA Health Adult Congenital Heart Disease (ACHD) Research Highlights
Learn More About Clinical Trials
See research summaries below, and if you have questions or would like to be included in research trials, please contact our research coordinator Tyler Kim at [email protected].
Proteus Trial for Transcatheter Pulmonary Valve Implantation
This is a prospective FDA-mandated trial of the Venus P valve for treatment of patients with pulmonary valve regurgitation. The Venus P valve is a self-expanding porcine transcatheter pulmonary valve platform that is placed through the femoral vein or jugular vein without the need for open-heart surgery. This valve comes in 10 different sizes, providing more options to better fit individual patients. The study is currently enrolling patients at UCLA Health, where Dr. Aboulhosn is the principal investigator and implanting physician. Thus far, we have implanted 3 Venus P valves with excellent outcomes.
Fondap Study for Fontan Patients With Heart Failure
The Fondap study is enrolling UCLA Health Fontan patients in collaboration with the Johns Hopkins Adult Congenital Heart Disease Center. This study is looking at the potential benefits of dapagliflozin (trade name Farxiga) in patients with Fontan physiology. Dapagliflozin is one of the newest medications Jooha Park, FNP Tyler Kim used in patients with acquired heart failure and is among the first medications shown to be effective in patients with heart failure with preserved ejection fraction. As such, this medication is one of the main tools used today in heart failure.
As with many other multicenter medical therapy trials, ACHD patients were excluded from the initial trials of these medications. Therefore, further study is required to test how effective each medication is in complex ACHD patients, particularly single-ventricle patients with Fontan physiology. Thus far, we have enrolled 14 UCLA Health Fontan patients.
Self-Expanding RVOT Valve Evidence (SERVE) Registry
The SERVE registry is a comprehensive multicenter research initiative led by Nationwide Children’s Hospital. The primary objective of this project is to evaluate both the short- and long-term complications associated with self-expanding valves in the right ventricular outflow tract (RVOT). By collecting data over a five-year period — beginning in April 2021 and concluding in April 2026 — the study seeks to define the true incidence of issues such as endocarditis, frame fractures and restenosis. Beyond merely recording these events, the registry’s secondary aim is to determine specific risk factors and clinical outcomes, providing a clearer roadmap for future patient care and valve selection.
Advancing the “Treat to Close” Strategy in ASD/PAH Research
Historically, atrial septal defects (ASD) are closed only in the absence of pulmonary arterial hypertension (PAH), since PAH poses a high risk for acute right ventricular failure if the ASD is closed. This research focuses on the transition of patients from a nonrepairable status to a state where closure becomes a viable option. This study aims to describe contemporary practice patterns in an era where all three major classes of PAH-directed medications — endothelin receptor antagonists, phosphodiesterase-5 inhibitors and prostacyclin analogues — have become available in oral forms. By using these modern medications to lower pulmonary pressures, clinicians may be able to pretreat the patient’s vasculature, effectively preparing the heart for the eventual closure of the septal defect.
A key component of the study is the evaluation of “fenestrated” closures. Rather than closing the ASD completely, a small opening (fenestration) is left in the closure device. This serves as a critical safety valve, allowing for right-to-left shunting of blood to maintain cardiac output if pulmonary pressures spike postoperatively. The research seeks to document how clinicians decide between complete versus fenestrated closures and to analyze the resulting changes in right ventricular morphology and function.
Alterra Adaptive Clinical Trial
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with the Alterra Adaptive Pre-stent was FDA approved in 2021 for severe pulmonary regurgitation and right ventricular dysfunction. UCLA Health continues to enroll patients in the post-approval studies to monitor long-term performance up to 10 years.
Harmony Transcatheter Pulmonary Valve Post-approval Study
The Medtronic Harmony transcatheter pulmonary valve was FDA approved in 2021 for severe pulmonary regurgitation and right ventricular dysfunction. UCLA Health is enrolling patients in the post-approval study to monitor long-term performance up to 10 years.
CATAPULT-TOF
CATAPULT-TOF stands for “Catheter ablation of ventricular tachycardia before pulmonary valve replacement in repaired tetralogy of Fallot.” This is an international multicenter study investigating the value of preemptive EP studies and catheter ablation before transcatheter pulmonary valve replacement in tetralogy of Fallot patients. UCLA Health is leading this trial under principal investigator Jeremy Moore, MD, with 30 participating centers and approximately 400 patients in the registry.
MOCA-CHD
MOCA-CHD stands for “Multicenter outcomes of cardiac implantable electronic devices in adults with CHD”. This is an international multicenter study investigating different implant techniques and novel technologies for pacing and defibrillation in the ACHD population. One of the most important topics will be the outcomes of physiologic pacing for different congenital heart substrates. UCLA Health is leading this trial under principal investigator Dr. Jeremy Moore, with 10 participating centers and approximately 50 patients enrolled thus far.
Additional Electrophysiology Trials With UCLA Health as a Participating Center
Conduction system pacing in ACHD: multicenter – Europe
ISAAC (“Management of atrial fibrillation in adults with congenital heart disease”): multicenter – Europe
ICDs in univentricular hearts: multicenter – Europe
Impact of junctional rhythm in the Fontan population: multicenter – U.S.
Outcomes of pace and ablate strategy for atrial arrhythmia in ACHD: multicenter – Europe
Pulsed field ablation in congenital heart disease: multicenter – international
Leadless cardiac pacing in congenital heart disease: multicenter – international
Catheter ablation of atrial arrhythmia after Fontan operation: multicenter – international
Transcatheter Atrioventricular Valve Repair Using TEER Technology
Transcatheter edge-to-edge repair (TEER) is a minimally invasive catheter-based procedure designed to treat severe atrioventricular (mitral or tricuspid) regurgitation by clipping leaflets together and reducing backward flow. This is primarily used in high-risk patients who are not surgical candidates but are limited by heart failure symptoms related to the valve regurgitation.
In complex congenital heart disease, the unique anatomical substrates impacting the structure of mitral and tricuspid valves demand novel approaches to treatment and finding a nonsurgical or minimally invasive solution is always the priority in the most complex patients. Those with single ventricles and Fontan repairs are the most complex and are often significantly burdened by the negative impact of leaky atrioventricular valves.
The UCLA Health and UCSD ACHD and structural interventional teams are collaborating to advance the use of TEER technology in the treatment of severe atrioventricular valve regurgitation in ACHD patients. Thus far, they have enrolled 30 patients who were prohibitively high-risk surgical candidates due to multiple comorbidities such as liver or kidney dysfunction, lung problems, arrhythmias, obesity and so on. All 30 patients survived the procedure, but two required repeat TEER for success, and one had to go on to surgery to treat the valve regurgitation.
All patients had a reduction in atrioventricular valve regurgitation, with a substantial reduction in 90%. There were no procedural deaths. After 34 months of follow-up, two patients had died of non-TEER related causes, but the remaining patients showed significant improvement in heart failure symptoms, with 45% virtually free of symptoms.
TEER technology provides a nonsurgical option for managing severe atrioventricular valve regurgitation in complex congenital heart disease patients. Individualized decision-making with multispecialty teams is key to patient selection, and procedural TEE (transesophageal echocardiogram) expertise is essential, as well as meticulous long-term heart failure management. Neurocognitive and Psychosocial Outcomes in Adults With Congenital Heart Disease The American Heart Association recently published a consensus statement in February 2026, prioritizing neurocognitive and psychosocial outcomes in adults with congenital heart disease. To warrant a consensus statement, the AHA acknowledges the importance of an organized approach to recognizing, treating and researching the lifelong consequences of the neurologic, cognitive and psychological burden of congenital heart disease. A major knowledge gap is how cognitive and psychological functioning changes across adult life stages, since research has focused heavily on childhood. There is consensus that screening and neuropsychological care are core components of lifelong care and should be systematically integrated into ACHD management. The full publication can be accessed in the following link: ucla.in/BrainHealthACHD.
Neurocognitive and Psychosocial Outcomes in Adults With Congenital Heart Disease
The American Heart Association recently published a consensus statement in February 2026, prioritizing neurocognitive and psychosocial outcomes in adults with congenital heart disease. To warrant a consensus statement, the AHA acknowledges the importance of an organized approach to recognizing, treating and researching the lifelong consequences of the neurologic, cognitive and psychological burden of congenital heart disease.
A major knowledge gap is how cognitive and psychological functioning changes across adult life stages, since research has focused heavily on childhood. There is consensus that screening and neuropsychological care are core components of lifelong care and should be systematically integrated into ACHD management.
The full publication can be accessed in the following link: ucla.in/BrainHealthACHD.