Clinical trials: Single-ventricle
Congenital Heart Disease
Endothelin Blockade in Patients With Single Ventricle Physiology
Recent studies have shown beneficial effects of sildenafil in patients with single ventricle congenital heart disease. The purpose of this study is to determine whether Bosentan, a drug with similar effects, will have similar…
- Trial name
- NCT00989911
- Testing
- Bosentan
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- University of California, Los Angeles
Arrhythmias, Atrial Fibrillation
Evaluation of a Single-lead ECG Patch-based Telemetry System for In-hospital Monitoring
"This investigator-initiated, prospective, single-center clinical study evaluates the performance and clinical utility of a single-lead electrocardiogram (ECG) patch-based telemetry system for hospitalized patients who require…
- Conditions
- Arrhythmias, Atrial Fibrillation, Ventricular Tachycardia, Supraventricular Tachycardia
- Trial name
- NCT07260721
- Testing
- MEMO-Cue-based telemetry monitoring
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Yonsei University
Single Ventricle
Perioperative Treprostinil in Pediatric Patients Undergoing the Fontan Operation
The purpose of this study is to test the efficacy of treprostinil (TRE) in the perioperative non-fenestrated, extracardiac Fontan patients in order to reduce duration of chest tube drainage (in days).
- Trial name
- NCT02498444
- Testing
- Treprostinil
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Stanford University
Univentricular Heart
Fontan-Sprechstunde
After successful Fontan surgery, the risk of mortality in childhood is only low. Unfortunately, some of the patients suffer from Fontan-typical long-term complications in the long-term course, whereby protein loss neuropathy must…
- Trial name
- NCT05563376
- Testing
- Univentricular Hearts
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
mHealth, Adherence, Patient
Parental Experience in the Single Ventricle Interstage Utilizing a mHealth Innovation: A Comparative Case Study
The purpose of this study is to provide a rich description of the parental perspectives of utilizing a mHealth application for data transfer during the single ventricle interstage monitoring period.
- Trial name
- NCT03231020
- Testing
- Interview
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Children's Mercy Hospital Kansas City
Heart Failure, Ventricular Dysfunction
Effects of Nesiritide in Pediatric Patients With Heart Failure
Children with severe heart failure need immediate appropriate care. New and better drugs are constantly being developed. As these drugs are approved for adult use, they are used off-label for children.
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Decompensation
- Trial name
- NCT00166010
- Testing
- Nesiritide
- Sponsor
- Emory University
Irregular Heart Rate
Ventricular Synchrony in Pediatric Patients
At Children's Healthcare of Atlanta, children who have irregular heart rhythms are often referred for evaluation. Sometimes they also need a procedure to correct their irregular heart rhythm.
- Trial name
- NCT00165932
- Where
- United States
- Volunteers
- 145 people
- Sponsor
- Emory University
Aortic Stenosis
Feasibility Study of the transShield Embolic Protection System
The objective of this study is to evaluate the initial safety and performance of the transShield EPS used for embolic protection during Transcatheter Aortic Valve Replacement (TAVR).
- Trial name
- NCT06652841
- Testing
- transShield Embolic Protection System
- Where
- New Zealand
- Volunteers
- 2 people
- Sponsor
- TransAortic Medical, Inc.
Cicatrix
Anti-Scarring Efficacy and Safety of Intradermal Juvista (Avotermin) in Healthy Males
This study was undertaken to investigate safety and scar-improvement activity of different applications of Juvista (avotermin), administered to surgical incisions made to the skin of a healthy population of male volunteers aged…
- Trial name
- NCT00594581
- Where
- United Kingdom
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Renovo
Fontan Circulation, Single Ventricle Heart Disease
CAMEO-FONTAN -Dapagliflozin in the Failing Fontan Circulation
The purpose of this research is to determine whether treatment with the study drug dapagliflozin for 3 months affects peripheral venous pressure at rest and during exercise in adults with failing Fontan circulation.
- Conditions
- Fontan Circulation, Single Ventricle Heart Disease, HFpEF - Heart Failure With Preserved Ejection Fraction
- Trial name
- NCT06762964
- Testing
- Dapagliflozin tablet
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Mayo Clinic
Congenital Heart Disease With Fontan Circulation
An Upcoming Clinical Study to Measure the Safety and Impact of a Drug Called Macitentan in Teenage and Adult Fontan Patients.
The aim of this open-label (OL) trial is to study the long-term use of macitentan for up to 2 years in Fontan-palliated adult and adolescent patients beyond the 52 weeks of treatment in the parent RUBATO double-blind (DB) study…
- Trial name
- RUBATO OL (NCT03775421)
- Testing
- macitentan 10 mg
- Where
- 19 sites in United States, Australia and 9 more
- Volunteers
- 112 people
- Sponsor
- Actelion
Tricuspid Atresia, Hypoplastic Left Heart Syndrome
Biomarker Study for Heart Failure in Children With Single Ventricle Physiology
The purpose of this study is to determine if children with heart disease where there is only one pumping chamber("ventricle") have proteins (biomarkers") in the blood that can be used to monitor the function of their heart.
- Conditions
- Tricuspid Atresia, Hypoplastic Left Heart Syndrome, Unbalanced AV Canal
- Trial name
- BHFSVP (NCT00571233)
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- University of California, San Francisco
Hypoplastic Left Heart Syndrome
SVRII Family Factors Study
The purpose of this study is to learn about the relationship between family factors and developmental and psychosocial outcomes in children with congenital heart disease at 6 years of age.
- Trial name
- NCT01582529
- Where
- 11 sites in United States, Canada
- Volunteers
- 187 people
- Sponsor
- Medical College of Wisconsin
Ischemic Cardiomyopathy, Catheter Ablation of Ventricular Tachycardia
Endo-epicardial vs Endocardial-only Catheter Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy (EPIC-VT)
Radiofrequency ablation of ventricular tachycardias (VTs) is the gold standard treatment of refractory VTs in patients with ischaemic heart disease. In this setting, ablation is usually performed endocardially.
- Trial name
- EPIC-VT (NCT05888662)
- Testing
- Endo-epicardial ablation, endocardial ablation only
- Where
- 12 sites in France
- Volunteers
- 150 people
- Sponsor
- Rennes University Hospital
Ventricular Tachycardia
Initial Management of Patients Receiving a Single Shock (IMPRESS)
The goal of this study is to determine the optimal treatment for patients who receive a single shock from their implantable cardioverter defibrillator (ICD).
- Trial name
- IMPRESS (NCT03531502)
- Testing
- Ventricular Tachycardia Ablation, Standard Medical Therapy, Non-Invasive Programmed Stimulation (NIPS)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Saint Luke's Health System
Congenital Heart Disease, Hypoplastic Left Heart Syndrome
Genetic Determinants of Congenital Heart Disease Outcomes
The purpose of this study is to examine the role of genetic variation in the oxidative stress response on critical perioperative and short-term outcomes after neonatal heart surgery.
- Conditions
- Congenital Heart Disease, Hypoplastic Left Heart Syndrome, Hypoplastic Right Heart Syndrome, d-Transposition of the Great Arteries
- Trial name
- GECHO (NCT01656941)
- Where
- 5 sites in United States, Australia
- Volunteers
- 250 people
- Sponsor
- University of Michigan
Coronary Artery Disease, Cardiac Valve Insufficiency
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure.
- Conditions
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- Trial name
- STERCCAS (NCT05439395)
- Testing
- Sternum Closure after Cardiac Surgery
- Where
- 2 sites in Germany, Spain
- Volunteers
- 229 people
- Sponsor
- Aesculap AG
Dopamine, Protein-Losing Enteropathies
Characterizing the Effect of Dopamine on Markers of Lymph Re-circulation in Fontan-associated Protein-losing Enteropathy
Patients that have undergone a Fontan procedure (surgical correction for single ventricle congenital heart disease) may develop a complication known as protein-losing enteropathy (PLE).
- Conditions
- Dopamine, Protein-Losing Enteropathies, Lymphatic System, Lymph
- Trial name
- NCT03322345
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Michigan
Single Ventricle Physiology
Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation…
- Trial name
- NCT02995577
- Testing
- Feeding tolerant, Feeding intolerant, Necrotizing enterocolitis
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center, Houston
Single-ventricle
Fibrosis and the Fontan
The purpose of this study is to non-invasively characterize the fibrotic consequences of single ventricle physiology, its possible solution and effect on lymphatics.
- Trial name
- NCT04901975
- Testing
- Spironolactone
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- Children's Hospital of Philadelphia