Clinical trials: Single-ventricle, open to volunteers
Univentricular Heart, Congenital Heart Disease
Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease
The goal of this clinical trial is to test the safety of lab-grown heart cells made from stem cells in subjects with congenital heart disease.
- Conditions
- Univentricular Heart, Congenital Heart Disease, Heart Failure NYHA Class III, Heart Failure NYHA Class IV
- Trial name
- NCT05647213
- Testing
- iPSC-CL
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HeartWorks, Inc.
Heart Failure Congenital, Single-ventricle
REHAB Fontan Failure: A Trial of Cardiac Rehabilitation
The goal of this clinical trial is to compare the impact of cardiac rehabilitation on Fontan failure patients' exertional tolerance, frailty, and quality of life. 1.
- Trial name
- NCT06150950
- Testing
- Cardiac rehabilitation, Usual care
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I
Right Ventricular Compensation With Sotatercept: A Prospective Single Arm Open Label Phase 4 Study to Evaluate the Effects of Sotatercept on Right Ventricular Function in Pulmonary Arterial Hypertension (RECOMPENSE)
Pulmonary arterial hypertension (PAH) is a progressive disease characterized by vascular remodelling resulting in elevated pressures in the pulmonary artery (PA).
- Conditions
- Pulmonary Arterial Hypertension PAH, Pulmonary Arterial Hypertension WHO Group I, Pulmonary Arterial Hypertension
- Trial name
- RECOMPENSE (NCT06658522)
- Testing
- Sotatercept
- Where
- Netherlands
- Volunteers
- 20 people
- Sponsor
- Amsterdam UMC, location VUmc
Congenital Heart Disease, Single-ventricle
Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery.
- Conditions
- Congenital Heart Disease, Single-ventricle, Thrombosis
- Trial name
- EVmiRNA (NCT06434207)
- Testing
- Collecting discarded blood samples
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Boston Children's Hospital
Heart Failure, Atrial Fibrillation (AF)
AI-Based Cardiac Analysis Using 12-Lead and 1-Lead ECG
This pilot study is designed to evaluate the clinical performance and utility of the SmartECG-EF software in patients undergoing evaluations at Inha University Hospital.
- Conditions
- Heart Failure, Atrial Fibrillation (AF), Electrocardiogram
- Trial name
- NCT07844434
- Testing
- SmartECG-EF
- Where
- South Korea
- Volunteers
- 300 people
- Sponsor
- Inha University Hospital
Aortic Valve Stenosis
To Evaluate Safety and Effectiveness of Transcatheter Aortic Valve System in Patients With Severe Aortic Stenosis
To Evaluate the Safety and Effectiveness of Transcatheter Aortic Valve System ( Chengdu Silara Medtech Inc. ,Chengdu, China)in Patients with Severe Aortic Stenosis with or without Moderate or Lower Degree Regurgitation
- Trial name
- NCT04893603
- Testing
- Transcatheter Aortic Valve System
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chengdu Silara Meditech Inc.
Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial…
- Trial name
- AFRVR (NCT07722039)
- Testing
- SMD-RVECG
- Volunteers
- 348 people
- Sponsor
- HUINNO Co., Ltd
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
Coronary Artery Disease (CAD)
Micro-axial Flow Pump-Supported PCI in Complex Coronary Artery Disease With Ischemic LV Dysfunction
Based on a multi-center randomized controlled study, this research aims to evaluate the efficacy and safety of interventional therapy supported by the CorVad percutaneous left ventricular assist system (Micro-axial Flow Pump） for…
- Trial name
- PIVOT (NCT07678021)
- Testing
- Microaxial pump-supported PCI, Optimal medical therapy (OMT)
- Where
- China
- Volunteers
- 452 people
- Sponsor
- China National Center for Cardiovascular Diseases
Cardiogenic Shock
Safety and Efficacy of the Extracorporeal Ventricular Assist System in Car Diogenic Shock: A Prospective, Multicenter , Single-Arm Study
Study Title: Safety and Efficacy of Extracorporeal Ventricular Assist System for Cardiogenic Shock: A Prospective, Multicenter, Single-Arm Clinical Study Objective: To evaluate the safety and efficacy of temporary mechanical…
- Trial name
- NCT07769528
- Testing
- EVAS Treatment
- Where
- China
- Volunteers
- 40 people
- Sponsor
- China National Center for Cardiovascular Diseases
Aortic Stenosis Treated With TAVI, Aortic Diseases
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
The objective of this pivotal study is to compare the safety and effectiveness of the F2 CPC (Treatment group) to a Control group (no embolic protection) in participants undergoing transfemoral (TF) TAVR with commercially…
- Trial name
- SHIELD (NCT06689839)
- Testing
- F2 Filter and Delivery System, Transcatheter Aortic Valve Replacement (TAVR)
- Where
- 10 sites in United States, Australia
- Volunteers
- 500 people
- Sponsor
- EnCompass Technologies, Inc.
Non-severe Pulmonary Embolism, Pulmonary Embolism
Interest of the Chair Lift Test in the Prognostic Evaluation of Pulmonary Embolism: a Single-center Open Prospective Study
The objective of the study is to evaluate the prognostic performance of the chair lift test in the initial assessment of the severity of non-severe pulmonary embolism in hospitalized patients, in comparison with the current…
- Conditions
- Non-severe Pulmonary Embolism, Pulmonary Embolism, Non-high-risk Pulmonary Embolism, Pulmonary Embolism Acute
- Trial name
- SIT-EP (NCT06166329)
- Testing
- chair lift test
- Where
- France
- Volunteers
- 180 people
- Sponsor
- University Hospital, Rouen
Single-ventricle, Congenital Heart Disease
Fontan Fitness Trial
The goal of this randomized control trial is to learn about physical fitness and exercise habits in children aged 10-17 with the Fontan Circulation through a home-based, digital exercise intervention.
- Trial name
- NCT06918795
- Testing
- Digital Exercise Intervention
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Children's Hospital of Philadelphia
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
Hypoplastic Left Heart Syndrome, Single Ventricle
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
- Trial name
- APOLLON (NCT02781922)
- Testing
- Autologous cardiac stem cells (JRM-001)
- Where
- 4 sites in Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Out of Hospital Cardiac Arrest, Ventricular Fibrillation
Early Double Sequential Defibrillation in Out of Hospital Cardiac Arrest
Some of the patients affected by Out-of-hospital cardiac arrest (OHCA) with ventricular fibrillation (VF)/ventricular tachycardia (VT) do not respond to initial defibrillation.
- Conditions
- Out of Hospital Cardiac Arrest, Ventricular Fibrillation, Defibrillation, CPR
- Trial name
- DOUBLE D (NCT07174986)
- Testing
- Double sequential defibirllation, Standard defibrillation
- Where
- 14 sites in Netherlands, Spain and 1 more
- Volunteers
- 916 people
- Sponsor
- Gabriel Riva
Ventricular Tachycardia
Dose Escalation for SBRT of Recurrent VT Ventricular Tachyarrhythmia - a Single Center, Phase II Clinical Trial
The objective of this study is to demonstrate that higher radiation doses are necessary to induce transmural scar formation which is currently assumed to be the underlying mechanism of successful long-term efficacy of VT…
- Trial name
- DEFT STAR (NCT05594368)
- Testing
- Dose escalating stereotactic arrhythmia radioablation to treat ventricular tachycardia (VT)
- Where
- 3 sites in Czechia, Switzerland
- Volunteers
- 15 people
- Sponsor
- University of Zurich
Cardiogenic Shock
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the…
- Trial name
- COURAGE (NCT07560085)
- Testing
- SynFlow Duro
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd
Advanced Heart Failure
DuoCor 2 DOMINATE Study
Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation.
- Trial name
- NCT07233876
- Testing
- DuoCor Ventricular Assist System
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Severe Aortic Valve Stenosis
Personalized, CT-guided Antithrombotic Therapy Versus Lifelong Single Antiplatelet Therapy to Reduce Thromboembolic and Bleeding Events in Non-atrial Fibrillation Patients After Transcatheter Aortic Valve Implantation
The POPular ATLANTIS trial aims to investigate CT-guided antithrombotic therapy compared to lifelong single antiplatelet therapy after a transcatheter aortic valve implantation (TAVI) procedure.
- Trial name
- POP ATLANTIS (NCT06168370)
- Testing
- CT guided strategy
- Where
- Netherlands
- Volunteers
- 2,500 people
- Sponsor
- St. Antonius Hospital