Clinical trials: Single Ventricle Heart Disease
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
HLH - Hypoplastic Left Heart Syndrome, DORV
Two-Year Study of the Safety and Efficacy of the Second-Generation Tissue Engineered Vascular Grafts
A single arm clinical trial evaluating the safety and efficacy of the second generation TEVG as vascular conduits for extracardiac total cavopulmonary connection.
- Conditions
- HLH - Hypoplastic Left Heart Syndrome, DORV, DILV - Double Inlet Left Ventricle, Mitral Atresia
- Trial name
- TEVG-2 (NCT04467671)
- Testing
- Tissue Engineered Vascular Grafts
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Nationwide Children's Hospital
Functional Single Ventricle Heart Disease
A Extension Study of Udenafil in Adolescents
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart…
- Trial name
- FUELExten (NCT03013751)
- Testing
- Udenafil
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Mezzion Pharma Co. Ltd
Aortic Stenosis
VitaFlow™ II Transcatheter Aortic Valve System Pre-market Trial
This is a pre-market clinical investigation aiming to evaluate the safety and effectiveness of Microport™ CardioFlow VitaFlow™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Premature Ventricular Contraction
Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
Arrhythmia is a common disease that may be caused by various cardiovascular diseases. According to statistics, 500,000 people die of severe arrhythmia every year in China, In the United States, approximately 540,000 patients die…
- Trial name
- NCT01235156
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Furui Pharmaceuticals Co., Ltd
Pulmonary Thromboembolisms, Pulmonary Embolism
Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD
In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen…
- Trial name
- NCT01531829
- Testing
- Recombinant tissue plasminogen activator (rt-PA), Low Molecular Weight Heparin
- Where
- 35 sites in China
- Volunteers
- 460 people
- Sponsor
- Beijing Chao Yang Hospital
Congenital Heart Defect
Exclusive Human Milk Feeding in Infants With Single Ventricle Physiology
A randomized, blinded, controlled trial to evaluate growth velocity and clinical outcomes in infants with single ventricle physiology fed an exclusive human milk diet prior to, and throughout the post-operative period following…
- Trial name
- NCT02860702
- Testing
- Human Milk Derived Fortifier, Human/Bovine Milk
- Where
- 12 sites in United States
- Volunteers
- 16 people
- Sponsor
- The University of Texas Health Science Center at San Antonio
Pulmonary Arterial Hypertension
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year.
- Trial name
- REPAIR (NCT02310672)
- Testing
- Macitentan
- Where
- 41 sites in United States, Australia and 10 more
- Volunteers
- 89 people
- Sponsor
- Actelion
Single-ventricle, Heart Diseases
Colchicine in Postoperative Fontan Patients
The investigators found that there is inflammation in the chest drainage in patients after the Fontan operation. The investigators want to test the theory that Colchicine, an anti- inflammatory medication, can decrease the…
- Trial name
- CPFP (NCT03575572)
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Michigan
Cardiogenic Shock
An Interventional Left Ventricular Assist System for Cardiogenic Shock
Imported Impella The price is relatively expensive and difficult for ordinary patients to afford. In order to better meet the growing clinical needs in China, Anhui Tongling Bionic Technology Co., Ltd.
- Trial name
- NCT06127927
- Testing
- Interventional Left Ventricular Assist System
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- Fujian Medical University
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
Ventricular Tachycardia, Ischemic Cardiomyopathy
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy
Over the last decade, radiofrequency catheter ablation (RFCA) has become an established treatment for ventricular arrhythmias (VA).
- Trial name
- AIM-VT (NCT06138873)
- Testing
- Ablation-index guided ventricular tachycardia ablation, Ventricular tachycardia ablation with no AI-guidance
- Where
- 5 sites in United States
- Volunteers
- 100 people
- Sponsor
- Rush University Medical Center
Single-ventricle, Pulmonary Hypertension
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
In univentricular hearts, selective lung vasodilators such as phosphodiesterase type 5 (PDE5) inhibitors would decrease pulmonary resistance and improve exercise tolerance.
- Conditions
- Single-ventricle, Pulmonary Hypertension, Univentricular Heart
- Trial name
- VU-INHIB (NCT03997097)
- Testing
- Sildenafil
- Sponsor
- University Hospital, Montpellier
Single-ventricle, Myocardial Fibrosis
Multimodality Biomarkers for Noninvasive Assessment of the Fontan Patient
This is a single center prospective longitudinal exercise training study and will enroll approximately 50 Fontan patients and 20 controls of a similar age, gender, BMI and physical activity level between the ages of 10-40 years.
- Trial name
- NCT03263312
- Testing
- Exercise
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Maria Bano
Critical Illness, Elevated Left Atrial Pressure
The Use of Single-Beat TE-e' in Evaluation of Left Atrial Pressure in Critically Ill Patients: The TELAP-ICU Trial
This study evaluates a new single-beat echocardiographic technique (TE-e', the time difference between the onset of the mitral inflow E wave and the septal e' wave on tissue Doppler imaging) for estimating left atrial pressure…
- Conditions
- Critical Illness, Elevated Left Atrial Pressure, Left Ventricular Diastolic Dysfunction, Echocardiography
- Trial name
- TELAP-ICU (NCT07820319)
- Testing
- Echocardiography
- Where
- Hong Kong
- Volunteers
- 50 people
- Sponsor
- Queen Mary Hospital, Hong Kong
Heart Diseases
A Phase I Study to Assess the Electrophysiologic Effects of BMS-394136 on the Atrium and Ventricle in Patients With Dual-Chamber Pacemakers or Defibrillators
Double-Blind, Randomized, Single-Dose Study to Evaluate the Atrial Selectivity and Safety of BMS-394136 in Subjects with Implanted Dual-Chamber Pacemakers or Defibrillators
- Trial name
- NCT00162448
- Testing
- BMS-394136
- Where
- 3 sites in United States
- Volunteers
- 36 people
- Sponsor
- Bristol-Myers Squibb
Single-ventricle, Fontan Circulation
Venous Compression in Fontan
The aim of this study is to investigate whether venous compression garments increase exercise stroke volume in patients with Fontan circulation. To address this aim, we will test the following hypotheses: 1.
- Trial name
- NCT07220226
- Testing
- Lower extremity compression garments, Without compression garments
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Single Ventricle Physiology
Training in Exercise Activities and Motion for Growth
To determine if an exercise program of passive range of motion (ROM) is safe and feasible in infants with single ventricle (SV) physiology after their Norwood procedure.
- Trial name
- T4G (NCT01917084)
- Testing
- Passive range of motion (ROM) exercise
- Where
- 3 sites in United States
- Volunteers
- 20 people
- Sponsor
- Carelon Research
Pleural Effusion, Single-ventricle
Use of Vasopressin Following the Fontan Operation
The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.
- Trial name
- NCT02975999
- Testing
- Vasopressin, Normal Saline
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Wake Forest University Health Sciences
Pulmonary Hypertension, Heart Failure
Frailty in Children With Cardiac Disease
Frailty is a complex biologic syndrome of diminished physiologic reserve that leads to decreased resistance to stressors and is associated with adverse health outcomes.
- Conditions
- Pulmonary Hypertension, Heart Failure, Single Ventricle
- Trial name
- NCT02999438
- Testing
- Actigraph to check activity levels at home
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Children's Mercy Hospital Kansas City