Congenital Heart Disease Clinical Trials

As a patient at Cedars-Sinai, you will have access to the latest clinical trials and research for congenital heart disease. Backed by a respected team of specialists and researchers, our clinical trials aim to further the advancement of diagnosing and treating your condition.

Questions? See the Clinical Trials FAQs.

Condition: 

Patent ductus arteriosus

Key Inclusion Criteria:

  • Diagnosis of a PDA
  • PDA ≤4 mm in diameter
  • PDA ≥3 mm in length

Summary:

The purpose of this study is to evaluate whether an investigational medical device called the AMPLATZER Duct Occluder II Additional Sizes (ADO II AS, also known as Piccolo) is safe and effective for the treatment of patent ductus arteriosus (PDA). The ductus arteriosus is an open channel in every fetus that allows blood to bypass the lungs. Within the first few days after a baby's first breath, the ductus arteriosus should close permanently. If it does not close, it remains open and is known as a PDA. The study will focus only on the ADO II AS device in patients with a PDA of less than 4 mm in diameter.

(This study is no longer enrolling patients.)

Condition: 

Congenital heart disease

Key Inclusion Criteria:

  • Diagnosis and/or management of anomalous aortic origin of a coronary artery (AAOCA) at a Congenital Heart Surgeons Society member institution from January 1, 1998 forward
  • ≤30 years old at the time of diagnosis
  • Structurally normal heart or with small, hemodynamically insignificant lesion (lesion that does not significantly affect blood flow)

Summary:

This research registry focuses on patients who have an abnormal coronary artery that has been present since birth. The purpose of the study is to gather information from children and young adults with congenitally abnormal coronary arteries (AAOCA) in North and South American hospitals. Researchers aim to understand the differences in outcomes of AAOCA patients among those who undergo surgery to correct their arteries and those who do not. To this end, patients will be asked to complete questionnaires, and researchers will collect information from medical records about diagnoses, medications, tests and hospitalizations/surgeries (if applicable).

Condition: 

Congenital heart disease

Key Inclusion Criteria:

  • Diagnosis of or referral with complete atrioventricular septal defect (AVSD) at a Congenital Heart Surgeons Society (CHSS) member institution within the first year of life
  • ≤365 days old at admission for surgery
  • Admitted to CHSS institution for surgery after January 1, 2012

Summary:

The purpose of this research registry is to gather information across hospitals in North and South America from patients with atrioventricular septal defect (AVSD). Patients with AVSD have a hole between the two upper chambers of the heart and a hole between the two lower chambers of the heart, as well as one combined heart valve between the upper and lower chambers of the heart (where there should be two). Researchers aim to understand the differences in outcomes of patients with AVSD in light of their medical characteristics and treatment. To this end, medical records will be reviewed, and participants will be asked to complete questionnaires about medications, exercise limitations, surgery or procedures and overall quality of life.

Condition: 

Cardiac disease, thromboembolism

Key Inclusion Criteria:

  • Children with cardiac diseases who are at risk for thromboembolic complications (blood clots) and who require at least 3 months of anticoagulant preventive treatment. Either one of the following criteria may apply:
    • Children with cardiac disease who have a history of cardiac shunt occlusion (blockage)/thrombosis with shunt still in place OR
    • Children with cardiac disease who require anticoagulation for primary prevention of thromboembolism (TE)

Summary:

The purpose of this study is to examine the safety and effectiveness of a drug called edoxaban in children with cardiac diseases who are at risk of thromboembolic complications (blood clots) and require anticoagulation (blood thinning) medicine to prevent blood clots. The study aims to determine whether edoxaban is better than the standard treatment for such children. The study also seeks to learn how patients' blood tests may change after taking the drug. Participants will be randomly assigned to receive either the usual standard-of-care anticoagulants (e.g., heparin, vitamin K antagonists) or edoxaban. Edoxaban is an investigational drug in children that may reduce blood clots.

Condition: 

Fontan physiology

Key Inclusion Criteria:

  • Males and females with Fontan physiology who participated in the FUEL trial or, if they did not participate in FUEL, those who are 12 to less than 19 years of age
  • Fluent in English, Spanish, or Korean
  • Participant consent or parental/guardian consent and participant assent

Summary:

This study focuses on patients who have had a Fontan surgery and who are between 12 and 18 years old. Over time, children and young adults who have had Fontan operation experience a decline in heart function. Often the first sign is a decrease in their exercise ability. The purpose of the study is to evaluate the effects of an investigational drug called udenafil and to determine whether adolescents who have had the Fontan operation can improve their ability to exercise by taking the drug. Udenafil works by making it easier for blood to flow through the lungs and back to the heart. It may also improve overall circulation, including function of the blood vessels in the body and the heart itself. Udenafil has not been approved by the U.S. Food and Drug Administration for treatment of children who have had a Fontan surgery.

A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM

Condition: 

Hypertrophic Cardiomyopathy, Obstructive Hypertrophic Cardiomyopathy, Non-obstructive Hypertrophic Cardiomyopathy

Condition: 

Congenital heart disease

Key Inclusion Criteria:

  • Newborn ≤30 days old at admission to a Congenital Heart Surgeons Society (CHSS) institution, with date of admission after December 31, 2004
  • With atrioventricular (AV) discordance and ventriculoarterial (VA) concordance (a rare form of congenital heart disease) whose left ventricular outflow obstruction prevents an adequate cardiac output through the aortic valve

Summary:

This research registry focuses on babies who have critical obstruction to blood leaving the left side of the heart to the body. The purpose of the study is to gather information from hospitals in North and South America about babies with this condition and to understand the differences in patient outcomes, depending on the type of surgery performed to correct the condition. Parents will complete questionnaires that ask about medications, exercise limitations, any surgery or procedures and overall quality of life.

A Phase 2 Study of Mavacamten in Adults With Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy (nHCM) (MAVERICK-HCM)

Condition: 

Non-obstructive Hypertrophic Cardiomyopathy

Condition: 

Congenital heart disease

Key Inclusion Criteria:

  • Diagnosis of tricuspid atresia with normally related great arteries
  • <3 months old at the time of diagnosis
  • Admitted to a Congenital Heart Surgeons Society (CHSS) institution on or after January 1, 1999

Summary:

The purpose of this research registry is to gather information across hospitals in North and South American from patients with tricuspid atresia (an absent right heart valve) who have had the condition since birth. Researchers aim to understand the differences in outcomes of these patients in light of their medical characteristics and treatment. To this end, medical records will be reviewed, and participants will be asked to complete questionnaires about medications, exercise limitations, surgeries or procedures and overall quality of life.