Clinical trials: Single Ventricle Heart Disease
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
Aortic Valve Stenosis
Protection by Remote Ischemic Preconditioning During Transcatheter Aortic Valve Implantation
Transcatheter aortic valve implantation (TAVI) has rapidly been adopted into clinical practice, but concerns have been raised regarding periprocedural complications like e.g. myocardial injury, stroke or acute kidney injury.
- Trial name
- NCT02080299
- Testing
- Remote ischemic preconditioning (RIPC)
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University Hospital, Essen
Single-ventricle, Stenosis
Transcatheter Fontan Stenting: Impact on Hepatic Stiffness and Exercise Capacity
The goal of this observational study is to assess the clinical impact following Fontan stent placement for extracardiac Fontan conduit (EFC) stenosis in patients with single-ventricle Fontan-palliated patients ages 12-21 years…
- Trial name
- NCT07073612
- Testing
- Cardiopulmonary Exercise Testing (CPET), Shear Wave Elastography Scan
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Children's Hospital Los Angeles
Single-ventricle
Impact of Early Fortini Initiation on Growth and Interstage Outcomes in Infants With Single Ventricle Physiology
This study is testing whether a special formula called Fortini, which is a high-calorie, low osmolality formula can help high-risk babies with single ventricle physiology grow better after their initial Stage 1 surgical…
- Trial name
- NCT07087782
- Testing
- Fortini formula, Standard Nutritional Care
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Driscoll Children's Hospital
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Aortic Valve Stenosis
The Leaflex™ Early Feasibility Study
A prospective, multicenter, single-arm, early feasibility study aimed to assess safety and performance of the Leaflex™ Performer in the treatment of patients with symptomatic, severe aortic stenosis.
- Trial name
- NCT04636073
- Testing
- Leaflex™ Performer
- Sponsor
- Pi-cardia
Hypertension, Pulmonary, Ventricular Dysfunction, Left
A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Diastolic Dysfunction
The aim of this study is to assess whether single oral doses of Riociguat safely improve the cardiovascular function in patients with pulmonary hypertension associated with left ventricular diastolic dysfunction
- Trial name
- DILATE (NCT01172756)
- Testing
- Riociguat (BAY63-2521)
- Where
- 7 sites in Austria, Czechia and 1 more
- Volunteers
- 39 people
- Sponsor
- Bayer
Diastolic Function
Determination of Diastolic Dysfunction by Single Lead Electrocardiogram
It is a prospective, controlled, single-center, non-randomized, observational study. From September 2019 to December 2020, the study plans to prospectively include 400 patients aged 18 to 90 years.
- Trial name
- NCT04474639
- Testing
- echocardiographic examination
- Where
- Russia
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- I.M. Sechenov First Moscow State Medical University
Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass
Adaptation of Alveolar-capillary Diffusion at Effort of Subjects Suffering From Complex Congenital Heart Disease
An injury of haematosis in post ischemic chronic heart failure limits the clinic tolerance. There is a correlation between injury of pulmonary diffusing, chronic heart failure intensity and aerobic physic ability evaluated by an…
- Conditions
- Complex Congenital Heart Disease, Single Ventricle With Fontan Circulation or Bicavo-bipulmonary Bypass, Systemic Right Ventricle, Pulmonary Failure
- Trial name
- CAR-DIFF (NCT02561975)
- Testing
- Double pulmonary diffusing
- Where
- France
- Volunteers
- 33 people
- Sponsor
- University Hospital, Montpellier
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
- Trial name
- HEARTWORK (NCT01065051)
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Bayer
Premature Ventricular Contractions, Congestive Heart Failure
Early Elimination of Premature Ventricular Contractions in Heart Failure
Premature ventricular contractions (PVC) are a very common irregular heart beat (arrhythmias) even in patients without heart disease. Frequent PVCs are thought to occur in about 1-4% of the general population.
- Trial name
- EVAC-HF (NCT01757067)
- Testing
- PVC ablation
- Where
- 8 sites in United States, Canada
- Volunteers
- 3 people
- Sponsor
- University of Maryland, Baltimore
Type 2 Diabetes Mellitus, Chronic Kidney Disease
Extended Release Exenatide Versus Placebo In Diabetic Patients With Type 4 Cardiorenal Syndrome
Among adult individuals with type 2 diabetes mellitus and at risk for heart failure with impaired relaxation of the heart mildly reduced kidney filtration function (Type 4 cardiorenal syndrome) this trial will evaluate the…
- Conditions
- Type 2 Diabetes Mellitus, Chronic Kidney Disease, Left Ventricular Diastolic Dysfunction
- Trial name
- NCT02251431
- Testing
- BYDUREON
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Baylor Research Institute
Single Ventricle Heart Disease After Fontan Surgery
Study of Effects of Sildenafil on Patients With Fontan Heart Circulation
The study will investigate the cardiovascular effects of sildenafil on patients with Fontan circulation. Recent studies suggest that sildenafil may improve exercise in patients with Fontan circulation.
- Trial name
- NCT01815502
- Testing
- Cardiac catheterization
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
Aortic Valve Stenosis, Structural Valve Deterioration
Single Perclose Escalation Technique for Vascular Closure in TAVR
This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end…
- Conditions
- Aortic Valve Stenosis, Structural Valve Deterioration, Structural Valve Degeneration
- Trial name
- NCT05836311
- Testing
- One Perclose Proglide Suture, Two Perclose Proglide Suture
- Where
- Spain
- Volunteers
- 300 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Heart Failure
Single Ascending Doses of GGF2 in Patients With Left Ventricular Dysfunction and Symptomatic Heart Failure
Study to determine the safety, tolerability, pharmacokinetics and immunogenicity of single intravenous administrations of GGF2 in patients with heart failure.
- Trial name
- GGF2-1101-1 (NCT01258387)
- Testing
- Glial growth factor 2/ Neuregulin 1β3
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- Acorda Therapeutics
Congenital Heart Disease, Nutritional Failure
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).
- Trial name
- NCT01821287
- Testing
- CHD
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Children's Hospital Medical Center, Cincinnati
Congenital Heart Disease
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
The international multicenter registry aims to collect real-world data on clinical outcomes and evaluate the net clinical success of transcatheter microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with…
- Trial name
- RESTRICT (NCT07791069)
- Testing
- Transcatheter pulmonary flow restriction
- Where
- 5 sites in France, Germany and 3 more
- Volunteers
- 150 people
- Sponsor
- Fondation Hôpital Saint-Joseph
Congenital Heart Disease
Transfusion Strategies in Pediatric Cardiothoracic Surgery
The purpose of this study is to determine the best red blood cell(hemoglobin) level for infants and children following surgical repair of particular heart defects.
- Trial name
- NCT00350220
- Testing
- transfusion strategy, Low Hb transfusion group
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- University of Rochester
Congenital Heart Defect, Single-ventricle
NIRS in Congenital Heart Defects - Correlation With Echocardiography
Neonatal patients with congenital heart defects (CHD) have changing physiology in the context of transitional period. Patients with CHD are at risk of low perfusion status or abnormal pulmonary blood flow.
- Conditions
- Congenital Heart Defect, Single-ventricle, Coarctation of Aorta, Atrioventricular Canal
- Trial name
- NCT04106479
- Testing
- NIRS evaluation
- Where
- Canada
- Volunteers
- 100 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Cardiomyopathies, Myocarditis
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the…
- Conditions
- Cardiomyopathies, Myocarditis, Inflammatory Cardiomyopathy, Heart Failure
- Trial name
- CMP-MYTHiC (NCT06158698)
- Testing
- Colchicine
- Where
- 10 sites in Italy
- Volunteers
- 80 people
- Sponsor
- Niguarda Hospital