Clinical trials: Single Ventricle
Healthy
Japan Central Aortic Pressure Prospective Study
Purpose of the study 1. The predictive value of central aortic pressure and aortic pulse wave velocity (PWV) in a Japanese population is not known.
- Trial name
- J-CARP (NCT01243840)
- Where
- Japan
- Volunteers
- 3,000 people, healthy volunteers welcome
- Sponsor
- Yoshio Matsui
Congenital Disorders
Outcomes of Children With Congenital Single Ventricle Heart
Congenital heart disease affects 1 in 100 newborn babies each year and more than 2,000,000 Americans have a congenital heart defect.
- Trial name
- NCT00266968
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Healthcare of Atlanta
Hypoplastic Left Heart Syndrome, Single Right Ventricle
Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease (PERSEUS)
The purpose of this study is to investigate the efficacy of intracoronary infusion of cardiac progenitor cells in patients with univentricular heart disease.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Right Ventricle, Single Left Ventricle
- Trial name
- NCT01829750
- Testing
- Cardiac progenitor cell infusion
- Where
- Japan
- Volunteers
- 34 people
- Sponsor
- Okayama University
Single-ventricle, Fontan Procedure
Exercise Capacity in Patients With Fontan Procedure
In literature, it has been reported that exercise capacity decreases in single-ventricle patients undergoing Fontan Procedure due to various factors related to surgery and underlying cardiac anomaly.
- Trial name
- NCT05063903
- Testing
- Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition
- Where
- Turkey (Türkiye)
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Aortic Valve Stenosis
Safety Profile Evaluation of TICagrelor Alone Compared to a Combination of Lysine Acetylsalicylate-Clopidogrel in the Context of Transcatheter Aortic Valve Implantation (TAVI)
Transcatheter Aortic Valve Implantation (TAVI) is now the method of choice to treat aortic stenosis in old and frail patients. Antiplatelet therapy must be associated for the procedure and during few weeks after implantation in…
- Trial name
- TICTAVI (NCT02817789)
- Testing
- Ticagrelor alone, Combination lysine acetylsalicylate - clopidogrel
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Bordeaux
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Pediatric ALL, Congenital Heart Disease
Virtual Remote Physiological Monitoring Program of Children With Heart Disease
Infants and children with heart conditions require treatment in children's hospitals that are typically located in large cities.
- Conditions
- Pediatric ALL, Congenital Heart Disease, Single-ventricle, Biventricular Congestive Heart Failure
- Trial name
- NCT05034354
- Testing
- Remote physiological monitoring
- Where
- Canada
- Volunteers
- 23 people
- Sponsor
- University of Alberta
Aortic Valve Stenosis
Valvosoft First-In-Man Study in Severe Symptomatic Aortic Stenosis
This is a prospective, controlled, single-arm clinical investigation for the treatment of subjects with severe symptomatic aortic valve stenosis using Valvosoft® Pulsed Cavitational Ultrasound Therapy (PCUT) - First-In-man
- Trial name
- NCT03779620
- Testing
- Ultrasound treatment of Calcified aortic valve
- Where
- 2 sites in France, Netherlands
- Volunteers
- 30 people
- Sponsor
- Cardiawave SA
NSCLC
A Study of Furmonertinib Combined With Chemotherapy in the Treatment of NSCLC With Leptomeningeal Metastasis
Leptomeningeal metastasis is a fatal complication of advanced lung cancer. There is no standard treatment for leptomeningeal metastasis after third-generation EGFR-TKIs.
- Trial name
- NCT06339242
- Testing
- Furmonertinib
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Jiangsu Province Nanjing Brain Hospital
Acute Myocarditis
MYTHS-MR Trial (MYocarditis THerapy With Steroids in Patients With Mildly Reduced Ejection Fraction)
The goal of this clinical trial is to demonstrate the efficacy of pulsed intravenous methylprednisolone in a single-blind randomized controlled trial versus standard therapy in patients with acute myocarditis and a mildly reduced…
- Trial name
- MYTHS-MR (NCT05974462)
- Testing
- Methylprednisolone 125 MG, IV saline solution 0.9%
- Where
- 19 sites in Belgium, Italy and 2 more
- Volunteers
- 174 people
- Sponsor
- University Hospital, Antwerp
Hypoplastic Left Heart Syndrome
Positive Pressure Ventilation and Sternal Closure in HLHS
This study will examine the cardiopulmonary interactions that occur with increasing ventilator settings (PEEP and PIP) in neonates after stage I palliation for hypoplastic left heart syndrome before and after sternal closure.
- Trial name
- NCT02455713
- Testing
- PEEP and PIP
- Where
- Canada
- Sponsor
- The Hospital for Sick Children
Aortic Stenosis, Severe, Aortic Valve Stenosis
A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)
The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used…
- Trial name
- CONTINUUM-CT (NCT06596460)
- Testing
- TAVI planning CT (adapted)
- Where
- United Kingdom
- Volunteers
- 40 people
- Sponsor
- Barts & The London NHS Trust
Heart Defects
Single Ventricle Reconstruction Extension Study (SVR II) - Pediatric Heart Network
The Single Ventricle Reconstruction (SVR) Trial looked at how infants with single ventricle heart defects did after the first stage of surgery (Norwood operation).
- Trial name
- SVRII (NCT02110823)
- Volunteers
- 325 people
- Sponsor
- Carelon Research
Complex Congenital Heart Disease
National Registry of Adult Heart Failure Patients With Complex Congenital Heart Disease: Systemic Right Ventricle and Single Ventricle Treated With Sacubitril/Valsartan
Heart failure in adults with congenital heart disease is a major cause of morbidity and mortality. Patients with systemic right ventricle (SRV) and single ventricle (SV) are particularly at risk1, 2, 3.
- Trial name
- ISACC (NCT06149806)
- Testing
- Sacubitril / Valsartan Oral Tablet [Entresto]
- Where
- France
- Volunteers
- 50 people
- Sponsor
- University Hospital, Grenoble
End-stage Heart Failure
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.
- Trial name
- NCT05353816
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- 11 sites in China
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
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 Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial - 2
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent who have had the Fontan procedure.
- Trial name
- FUEL-2 (NCT05918211)
- Testing
- Udenafil
- Where
- 40 sites in United States, South Korea
- Volunteers
- 436 people
- Sponsor
- Mezzion Pharma Co. Ltd
Heart Defects, Congenital, Hypoplastic Left Heart Syndrome
Impact of Early Intervention on Maternal Stress in Mothers of Fetuses Diagnosed With Single Ventricle Physiology
This study evaluates maternal psychological distress and the impact of early palliative care team consultation on maternal anxiety and depression symptoms, coping, and quality of life/family functioning in the care of neonates…
- Conditions
- Heart Defects, Congenital, Hypoplastic Left Heart Syndrome, Single Ventricle Defect, Stress, Psychological
- Trial name
- NCT02462434
- Testing
- Early palliative care team consultation
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Pulmonary Arterial Hypertension
A Study of a Mean Pulmonary Artery Pressure-Targeted Approach With Early and Rapid Treprostinil Therapy to Reverse Right Ventricular Remodeling in Participants With Pulmonary Arterial Hypertension
The primary objective of this study is to assess the effect of early and rapid treprostinil therapy for mean pulmonary artery pressure (mPAP) reduction to improve right ventricular (RV) function and reverse RV remodeling in…
- Trial name
- ARTISAN (NCT05203510)
- Testing
- Parenteral Treprostinil, Oral Treprostinil
- Where
- 28 sites in United States
- Volunteers
- 52 people
- Sponsor
- United Therapeutics
Advanced Heart Failure
A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
- Trial name
- NCT07757451
- Testing
- DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.