Clinical trials: Single Ventricle Heart Disease
Decompensated Cirrhosis, Cirrhotic Cardiomyopathy
Carvedilol + Simvastatin vs. Carvedilol Alone for Cirrhosis and Cirrhotic Cardiomyopathy and Impact on Hepatic Decompensation and Survival
Cirrhosis and portal hypertension are associated with a hyperdynamic circulation and decompensation events, including development of ascites, variceal bleeding, acute kidney injury, and susceptibility to infections.
- Conditions
- Decompensated Cirrhosis, Cirrhotic Cardiomyopathy, Cirrhosis, Liver, Left Ventricular Diastolic Dysfunction
- Trial name
- CIRROSTAT (NCT06431919)
- Testing
- Simvastatin 20mg, Carvedilol 3.125 mg
- Where
- India
- Volunteers
- 260 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Single Ventricle Defect
Cerebral Blood Flow in Single Ventricles Throughout Staged Surgical Reconstruction
This study seeks to determine cerebral blood flow changes in single ventricle patients during staged surgical reconstruction as compared with normal children.
- Trial name
- CBF (NCT02135081)
- Where
- United States
- Volunteers
- 260 people
- Sponsor
- Children's Hospital of Philadelphia
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
- Trial name
- CAP (NCT01242891)
- Testing
- EXCOR® Pediatric Ventricular Assist Device
- Sponsor
- Berlin Heart, Inc
Congenital Heart Disease
Pulmonary Capillary Recruitment in Fontan Patients
This study evaluates the effects of pulmonary vasodilator therapy on pulmonary capillary blood flow by measuring the functional capillary surface area (FCSA) at baseline and post nitric oxide inhalation, through the injection of…
- Trial name
- NCT04292483
- Testing
- Nitric Oxide
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- Jewish General Hospital
Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation)
Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial
Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period.
- Conditions
- Aortic Stenosis, TAVI(Transcatheter Aortic Valve Implantation), Aspirin, DAPT(Dual Antiplatelet Therapy)
- Trial name
- NCT06007222
- Testing
- Aspirin group, Non-antithrombotic group
- Where
- Japan
- Volunteers
- 400 people
- Sponsor
- OCEAN-SHD Study Group
Stroke, Aortic Valve Stenosis
INTERvention With Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation (INTERCEPTavi)
The study aims to evaluate the processes of a pilot single-centre randomised controlled trial (RCT) of carbon-dioxide flushing of transcatheter aortic valves (TAVI-CO2) versus standard saline flushing of valves (TAVI-S) and…
- Conditions
- Stroke, Aortic Valve Stenosis, Silent Cerebral Infarct, Vascular Brain Injury
- Trial name
- INTERCEPTavi (NCT05146037)
- Testing
- CO2 and saline flushing, Saline flushing
- Where
- United Kingdom
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Single-ventricle, Congenital Heart Disease
Correlation Between 3D Echocardiography and Cardiopulmonary Exercise Testing in Patients With Single Ventricle
Congenital heart disease (CHD) is the leading cause of birth defects, with an incidence of 0.8%. Among CHD, univentricular heart disease or "single ventricle" is rare and complex.
- Trial name
- VU3D (NCT05118152)
- Where
- France
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- University Hospital, Montpellier
Single-ventricle, Hepatic Congestion
The Effect of Fontan Fenestration Closure on Hepatic Stiffness
The overarching goal of this project is to discern how closure of Fontan fenestrations in patients with single ventricle heart disease will affect hepatic congestion, a major determinant of chronic liver disease.
- Trial name
- NCT03481985
- Testing
- Fenestration status
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Boston Children's Hospital
Single-ventricle, Infant Conditions
PK/PD of Digoxin in Infants With SVHD
The primary participant will be an infant with single ventricle heart disease. This is a research study to learn more about how the medication digoxin, which is routinely prescribed to infants and children with heart disease in…
- Conditions
- Single-ventricle, Infant Conditions, Infant, Newborn, Diseases, Infant, Premature, Diseases
- Trial name
- Digoxin R01 (NCT06613477)
- Testing
- PK/PD Model Based Dosing of Digoxin in Infants with Single Ventricle Heart Disease
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Duke University
Aortic Valve Stenosis
VitaFlow™ 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™ Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04655742
- Testing
- VitaFlow™ Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Indication for Peripheral Intravenous Catheterization, Atrial Flutter
SHERLOCK 3CG™ Diamond Tip Confirmation System
This study is a single-arm, prospective, multi-center study to assess clinical performance of the SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) with MODUS II software for confirming correct tip position of peripherally…
- Conditions
- Indication for Peripheral Intravenous Catheterization, Atrial Flutter, Premature Atrial Contraction, Premature Ventricular Contraction
- Trial name
- MODUS II (NCT03288766)
- Testing
- PICC placement with SHERLOCK 3CG™ Diamond TCS with MODUS II software
- Where
- 8 sites in United States, Australia
- Volunteers
- 232 people
- Sponsor
- C. R. Bard
Univentricular Heart, Congenital Heart Disease
Lymphatic Function in Patients With Fontan Circulation: Effect of Physical Training
Background: The Fontan operation has been used to treat complex cardiac anomalies with a single-functioning ventricle. A study performed by Instituto do Coracão-Hospital das Clínicas-Universidade de Sao Paulo…
- Conditions
- Univentricular Heart, Congenital Heart Disease, Lymphatic Abnormalities, Functional Capacity
- Trial name
- NCT05934578
- Testing
- Exercise training
- Where
- Brazil
- Volunteers
- 20 people
- Sponsor
- University of Sao Paulo
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the…
- Trial name
- NCT00583661
- Testing
- EXCOR Pediatric
- Where
- 17 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Berlin Heart, Inc
Single-ventricle, Congenital Heart Disease
Enhanced External Counterpulsation in Patients With Fontan Circulation
The purpose of the proposed study is to determine the safety of enhanced external counterpulsation (EECP), a system for compressing the blood vessels in the legs in synchrony with an individual's cardiac rhythm, in clinically…
- Trial name
- NCT04956952
- Testing
- EECP
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Boston Children's Hospital
Single-ventricle, Pulmonary Vascular Resistance Abnormality
ET1 Concentration, Metabolic Pathway Activation, and Pulmonary Blood Flow in Infants Undergoing Superior Cavo-Pulmonary Anastomosis
This is a novel preliminary study of biomarkers of pathologic pre-operative pulmonary vascular development, elevated pre-operative Pulmonary Vascular Resistance Index (PVRi), and complications associated with decreased…
- Conditions
- Single-ventricle, Pulmonary Vascular Resistance Abnormality, Superior Cavo-Pulmonary Anastomosis, Endothelin
- Trial name
- NCT03404258
- Testing
- Research Blood Sampling
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Colorado, Denver
Congenital Heart Disease, SRV Dependent
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Researchers want to better understand what happens to the heart when the autologous (from one's own body) stem cells are injected directly into muscle of the right side of the heart during the Fontan (Stage III) surgery.
- Trial name
- NCT04907526
- Testing
- Autologous mononuclear cells
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Timothy J Nelson, MD, PhD
Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia
A Multicenter Study of Pulsed Field Ablation for Paroxysmal Supraventricular Tachycardia
The purpose of this study was to explore the safety and efficacy of pulsed field ablation（PFA) in the treatment of paroxysmal pupraventricular pachycardia（PSVT）with a contact force(CF)-sensing PFA Catheter
- Conditions
- Paroxysmal Supraventricular Tachycardia, Atrioventricular Nodal Reentrant Tachycardia, Atrioventricular Reciprocating Tachycardia
- Trial name
- PSVT (NCT05820035)
- Testing
- Pulsed Field Ablation Device and CF-Sensing Pulsed Field Ablation Catheter
- Where
- China
- Volunteers
- 164 people
- Sponsor
- Shanghai MicroPort EP MedTech Co., Ltd.
Heart Failure, Diastolic
Stratified Treatment to Ameliorate Diastolic Left Ventricular Stiffness in Heart Failure With Preserved Ejection Fraction
A 35-week, single-center, prospective, double-blind, controlled, randomized, 2x2 crossover, interventional Phase II study, investigating the effect of treatment with dapagliflozin 10mg od on Left Ventricular distensibility in…
- Trial name
- STADIA-HFpEF (NCT04475042)
- Testing
- Dapagliflozin
- Where
- Netherlands
- Volunteers
- 26 people
- Sponsor
- Mariëlle Scheffer
Congenital Heart Disease (CHD), Univentricular Heart
Fontan Outcomes in Oligemia vs Plethora in Univentricular CHD
This prospective cohort study evaluates differences in clinical outcomes between pulmonary oligemia and pulmonary plethora in patients with cyanotic congenital heart disease and univentricular heart physiology undergoing staged…
- Trial name
- NCT07535203
- Testing
- Fontan Procedure
- Where
- Indonesia
- Volunteers
- 52 people
- Sponsor
- Sisca Natalia Siagian
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