Clinical trials: Single Ventricle Heart Disease
Fontan Procedure, Hypoplastic Left Heart Syndrome
Global and Regional Myocardial Strain and Power Output In Patients With Single Ventricles Using Novel MRI Techniques
The investigators are beginning a clinical research study here at UCSF to learn more about how hearts with single ventricles work.
- Conditions
- Fontan Procedure, Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Double Inlet Left Ventricle
- Trial name
- NCT01107990
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Hypoxia, Altitude, Hypoxia
Effect of Acute Hypoxia on RIght VEntRicular Function in Asthma.
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, Altitude, Hypoxia, Normobaric Hypoxia, Right Ventricular Function
- Trial name
- RIVER-Asthma (NCT07431580)
- Testing
- Normobaric Hypoxia
- Where
- Switzerland
- Volunteers
- 18 people
- Sponsor
- Mona Lichtblau
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Tachyarrhythmia
Study to Verify Proper Detection of Supraventricular Tachyarrhythmia With Single-Lead Dual-Chamber Implantable Cardioverter-Defibrillators (ADRIA)
A unique single-lead dual-chamber implantable cardioverter-defibrillator (ICD) system (produced by Biotronik, Germany) features a conventional electrode in the ventricle (anchored in the ventricular apex) and a floating electrode…
- Trial name
- NCT00324662
- Testing
- Implantable cardioverter-defibrillator
- Where
- 10 sites in Germany, Switzerland
- Volunteers
- 260 people
- Sponsor
- Biotronik SE & Co. KG
Hypoplastic Left Heart Syndrome, Tricuspid Atresia
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
The purpose of this study is to determine whether Bosentan is an effective and safe treatment to adolescent and adult (15 years and older) patients, born with one ventricle of the heart instead of two (single ventricle…
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Trial name
- TEMPO (NCT01292551)
- Testing
- Bosentan
- Where
- 4 sites in Denmark, Sweden
- Volunteers
- 75 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Congenital Heart Disease
Influence of Genetic Polymorphisms on Ventricular Structure and Function in Patients With Single Ventricle Anatomy
There are many kids born with congenital heart disease. Some of these defects may lead to the formation of a single ventricle (the heart having only one pumping chamber).
- Trial name
- NCT00165984
- Where
- United States
- Volunteers
- 224 people
- Sponsor
- Emory University
Aortic Valve Calcification, Aortic Valve Stenosis
VALVOSOFT® Pivotal Study
The objective of the study is to evaluate the safety and performance of a new non-invasive ultrasound therapy (NIUT) with Valvosoft in the treatment of Calified Aortic Stenosis
- Trial name
- NCT05235568
- Testing
- VALVOSFT intervention
- Where
- 11 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Cardiawave SA
Ischemic Heart Failure
PARACHUTE China Approval Trial
The design of this study is a multi-center, prospective, single-arm clinical trial to evaluate the safety and efficacy of the Parachute percutaneous left ventricle partitioning system.
- Trial name
- NCT02240940
- Testing
- Parachute Implant
- Where
- 7 sites in China
- Volunteers
- 30 people
- Sponsor
- CardioKinetix, Inc
Adult Congenital Heart Disease, Congenital Heart Disease
Adult Congenital Heart Disease International EValuation of the Effectiveness of SGLT2i Registry
This real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (SGLT2i) in adult congenital heart disease (ACHD) patients by investigating the prescription patterns…
- Conditions
- Adult Congenital Heart Disease, Congenital Heart Disease, Systemic Right Ventricle, Transposition of the Great Arteries
- Trial name
- ACHIEVE-SGLT2i (NCT06932081)
- Testing
- SGLT2 inhibitors
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 400 people
- Sponsor
- Leiden University Medical Center
Congenital Heart Disease, Single Ventricle
Diffuse Myocardial Fibrosis in Fontan Patients
The purpose of this protocol is to measure the relaxation of the heart in subjects with single ventricles who have undergone the surgical Fontan procedure.
- Conditions
- Congenital Heart Disease, Single Ventricle, Myocardial Fibrosis
- Trial name
- NCT01929174
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Oregon Health and Science University
Ventricular Tachycardia, Arrhythmia
Stereotactic Arrhythmia Radioablation for Ventricular Tachycardia (StAR-VT)
In 2017 a novel treatment approach to a series of 5 patients with refractory VT was introduced, using ablative radiation with a stereotactic body radiation therapy (SBRT) technique to arrhythmogenic scar regions defined by…
- Conditions
- Ventricular Tachycardia, Arrhythmia, Arrhythmic Storm, Radiation Toxicity
- Trial name
- StAR-VT (NCT05258422)
- Testing
- stereotactic body radiotherapy, 20 Gy in 1 fraction
- Where
- Canada
- Volunteers
- 9 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Single Ventricle Heart Disease
Evaluation of Fontan-associated Hepatic Stiffness and the Efficacy of Udenafil in Reducing Liver Stiffness
A study to evaluate the efficacy of MZ101 therapy in reducing liver stiffness.
- Trial name
- FALD (NCT03430583)
- Testing
- Udenafil
- Where
- 17 sites in United States, Canada
- Volunteers
- 88 people
- Sponsor
- Mezzion Pharma Co. Ltd
Heart Failure, Essential Hypertension
LCZ696 in Advanced LV Hypertrophy and HFpEF
Patients with advanced LVH and HFpEF will be randomly assigned in open-label fashion to receive LCZ696 titrated to 200 mg twice daily or valsartan titrated to 160 mg twice daily, and will be treated for 24 weeks.
- Trial name
- NCT03928158
- Testing
- LCZ 696, Valsartan
- Where
- Russia
- Volunteers
- 61 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Ventricular Tachycardia
Modification of the Local Abnormal Ventricular Activity Only
Local abnormal ventricular activity (LAVA) is composed of high-frequency, mainly low voltage signals that represent near-field signals from slow-conducting tissue and thus potential VT isthmuses.
- Trial name
- LAVAONLY (NCT05331716)
- Testing
- Cardiac ablation therapy
- Where
- Germany
- Volunteers
- 22 people
- Sponsor
- University of Kiel
Transcatheter Aortic Valve Replacement
Safety and Efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System
This study was designed to preliminary verify the safety and of efficacy of SinocrownTM Transcatheter Aortic Valve Replacement System With accessories in patients with symptomatic, calcified and severe aortic stenosis using…
- Trial name
- NCT05202977
- Testing
- SinocrownTM Transcatheter Aortic Valve Replacement System
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Lepu Medical Technology (Beijing) Co., Ltd.
Heart Failure, Cardiomyopathy, Hypertrophic
A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.
- Conditions
- Heart Failure, Cardiomyopathy, Hypertrophic, Left Ventricular Hypertrophy
- Trial name
- NCT05646056
- Testing
- Software
- Where
- United States
- Volunteers
- 82 people
- Sponsor
- Prolaio
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 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
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
Severe Aortic Stenosis
Comparison of a Single Versus Double Perclose Technique for TAVR
Transcatheter aortic valve replacement (TAVR) has become widely recognized as a minimally invasive approach for aortic valve replacement in patients with severe aortic stenosis.
- Trial name
- Single (NCT06173115)
- Testing
- Perclose Proglide system
- Where
- 25 sites in China
- Volunteers
- 876 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine