Clinical trials: Single Ventricle Heart Disease
Heart Failure
Phase IIb Safety and Efficacy Study of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Moderate Chronic Kidney Disease Alone
This study will be conducted in subjects with clinical diagnosis of worsening chronic heart failure and either type 2 diabetes mellitus (DM) with or without chronic kidney disease (CKD) or moderate CKD alone treated with…
- Trial name
- ARTS-HF Japan (NCT01955694)
- Testing
- BAY94-8862, Eplerenone
- Where
- 29 sites in Japan
- Volunteers
- 72 people
- Sponsor
- Bayer
Coronary Stenosis, Aortic Valve Stenosis
Impact of Fast-rotation Coronary CT in Patients Undergoing Aortic Stenosis Workup
This study aims to evaluate the clinical value of a novel CT gantry supporting a .23 second rotation time and systematically compare it with 0.23 second rotation time, in patients with clinically indicated aortic CTA in the…
- Conditions
- Coronary Stenosis, Aortic Valve Stenosis, Cardiovascular Diseases
- Trial name
- FAST-CCT (NCT05709652)
- Testing
- Aortic CTA, .23s, Aortic CTA, .28s
- Where
- Switzerland
- Volunteers
- 124 people
- Sponsor
- David C. Rotzinger
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve System in Patients With Severe Calcific Aortic Stenosis
To observe and evaluate the safety and efficacy of TaurusOne® transcatheter aortic valve system in patients with severe calcific aortic stenosis through a prospective, multicenter clinical trial using objective performance…
- Trial name
- NCT04815785
- Testing
- TaurusOne® transcatheter aortic valve replacement system
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
Single-ventricle
Validation of Cardiac Magnetic Resonance Sequences in Patients With Single Ventricles
Single ventricle defects make up the severe end of the congenital heart disease spectrum. The Fontan operation leads to a complete redirection of systemic venous blood outside of the heart and directly into the lungs.
- Trial name
- NCT04017494
- Testing
- Cardiac Magnetic Resonance Imaging, Blood draw for hematocrit and heart failure biomarkers, Cardiopulmonary exercise test
- Where
- Switzerland
- Volunteers
- 63 people
- Sponsor
- Barbara Burkhardt
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Congenital Heart Disease
Pharmacokinetics and Safety Profile of Digoxin in Infants With Single Ventricle Congenital Heart Disease
This is a prospective, multi-center, open-label, PK and safety profile study of enteral digoxin in children <6 months old at time of enrollment, post-surgical or hybrid stage 1 palliation, but prior to surgical stage 2 palliation.
- Trial name
- DGX01 (NCT03877965)
- Testing
- Digoxin
- Where
- 11 sites in United States
- Volunteers
- 50 people
- Sponsor
- Christoph P Hornik, MD MPH
Single-ventricle, Fontan Procedure
Hemodynamic, Vascular and Muscular Parameters of Exercise Capacity in Single-Ventricle Patients With Fontan Procedure
After the Fontan procedure applied in patients with a functional or anatomical single ventricle, patients are faced with significant morbidity and mortality risk.
- Conditions
- Single-ventricle, Fontan Procedure, Hemodynamic Instability, Arterial Stiffness
- Trial name
- NCT05011565
- Testing
- Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function
- Where
- Turkey (Türkiye)
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Hacettepe University
Hypoplastic Left Heart Syndrome, Single Ventricle
Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single Ventricle Physiology
Hypoplastic left heart syndrome (HLHS) and related anomalies involved a single ventricle are characterized by hypoplasia of the left heart and the aorta with compromised systemic cardiac output.
- Conditions
- Hypoplastic Left Heart Syndrome, Single Ventricle, Heart Failure
- Trial name
- TICAP (NCT01273857)
- Testing
- Autologous cardiac progenitor cell transplantation, staged shunt procedure
- Where
- Japan
- Volunteers
- 14 people
- Sponsor
- Okayama University
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
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
Hypoplastic Left Heart Syndrome
Cerebral Anatomy, Hemodynamics and Metabolism
Single ventricle lesions are the leading cause of illness and death from congenital heart disease. The modified Fontan Operation is the corrective surgery for these lesions.
- Trial name
- NCT02919956
- Testing
- Magnetic Resonance Imaging, Neurodevelopmental Testing
- Where
- United States
- Volunteers
- 121 people, healthy volunteers welcome
- Sponsor
- Children's Hospital of Philadelphia
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Fontan Circulation
IMProving DRug Dosing and Outcomes for Single VEntricle Patients With Fontan Associated Liver Disease
This is a single center, open-label, prospective, investigation to quantify the effects liver congestion and fibrosis has on hepatic drug metabolism and transport in children, adolescents, and young adults with Fontan circulation.
- Trial name
- IMPROVE-FALD (NCT06324396)
- Testing
- Sildenafil 10mg oral tablet (participants <20kg), or 20mg oral tablet (participants ≥20kg), Pravastatin 20 mg oral tablet (ages <13 years), or 40 mg oral tablet (≥14 years)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Children's Mercy Hospital Kansas City
Ventricular Tachycardia
Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation on the Long Term Success Rate of VT Ablation
This study aims to assess whether a combined technique of substrate ablation and ablation of the clinically presenting VT at the site of early activation is superior to ablation of the clinically presenting VT alone, in enhancing…
- Trial name
- VISTA (NCT01045668)
- Testing
- Radiofrequency Catheter Ablation (RFCA)
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Texas Cardiac Arrhythmia Research Foundation
Heart Failure
MDT-1118 Japan DT Study
To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure.
- Trial name
- MDT-1118 Japan (NCT03884504)
- Testing
- Ventricular Assist Device System
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Defects, Congenital, Heart Failure, Congestive
Trial of Angiotensin Converting Enzyme Inhibition in Infants With Single Ventricle--Pediatric Heart Network
This study will evaluate the efficacy and safety of administering an angiotensin converting enzyme inhibitor (ACE-I) (enalapril) to infants with a functional single ventricle.
- Trial name
- ISV (NCT00113087)
- Testing
- Enalapril
- Where
- 9 sites in United States, Canada
- Volunteers
- 230 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Ventricular Arrhythmias, Atrial Fibrillation
Ventricular Arrhythmias After Pulmonary Vein Isolation
The investigators study aimed to observe the occurrence of new premature ventricular complexes and other ventricular arrhythmias after pulmonary vein isolation.
- Trial name
- NCT02699255
- Where
- Germany
- Volunteers
- 111 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
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
Hypoxia, Normobaric Hypoxia
Effect of Acute Hypoxia on RIght VEntRicular Function in Healthy Adults.
More and more people are engaging in sports in the mountains, including individuals with heart or lung diseases. At the same time, such diseases are becoming more common in Switzerland.
- Conditions
- Hypoxia, Normobaric Hypoxia, Altitude Hypoxia, Right Heart Function
- Trial name
- RIVER-H (NCT07431567)
- Testing
- Normobaric Hypoxia
- Where
- 2 sites in Switzerland
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Mona Lichtblau
Anemia
Iron Prophylaxis for Anemia in Infants With Cyanotic Congenital Heart Disease
Anemia is a common disorder in infants with one working chamber of the heart that pumps blood. Anemia is when the level of healthy blood cells becomes too low.
- Trial name
- NCT00459225
- Testing
- Iron (ferrous sulfate)
- Where
- United States
- Sponsor
- Emory University