Clinical trials: Single Ventricle Heart Disease
Aortic Stenosis
Safety and Efficacy of TaurusOne® Transcatheter Aortic Valve Replacement System With Retrievable Delivery Catheter System
The TaurusOne® transcatheter aortic valve system with retrievable delivery catheter system is evaluated the safety and effectiveness for the delivery of artificial aortic valve in a prospective, multicenter, single-arm clinical…
- Trial name
- NCT04744857
- Testing
- The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Peijia Medical Technology (Suzhou) Co., Ltd.
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
Aortic Valve Stenosis, Coronary Artery Disease
Evaluation of Fractional Flow Reserve Calculated by Computed Tomography Coronary Angiography in Patients Undergoing TAVR
The objective of this study is to evaluate the relationship between fractional flow reserve (FFR) derived from coronary computed tomography angiography (FFRct) before transcatheter aortic valve replacement (TAVR) and FFR after…
- Trial name
- FORTUNA (NCT03665389)
- Testing
- iFR / FFR measurement
- Volunteers
- 25 people
- Sponsor
- Kobe University
Heart Failure
A Single-blind Pilot Study to Investigate Safety and Tolerability of the Chymase Inhibitor BAY1142524 in Clinically Stable Patients With Left-ventricular Dysfunction
The purpose of the trial is the analysis of safety and tolerability of the chymase inhibitor BAY1142524 in comparison to placebo using a 2 weeks treatment period in clinically stable patients with left-ventricular dysfunction…
- Trial name
- CHIARA MIA 1 (NCT02452515)
- Testing
- BAY1142524
- Where
- 10 sites in Denmark, Germany and 1 more
- Volunteers
- 49 people
- Sponsor
- Bayer
Heart Failure, Left Bundle-Branch Block
LV Only MPP With SyncAV
The objective of this clinical investigation is to evaluate the clinical benefits of left ventricle (LV) only pacing combined with automatic adjustment of AV timing (SyncAV) in patients receiving cardiac resynchronization therapy…
- Trial name
- NCT03567096
- Testing
- BiV pacing with MPP and SyncAV, LV only pacing with MPP and SyncAV
- Where
- 6 sites in Canada, France and 2 more
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
Single Ventricle Heart Disease
Fontan Udenafil Exercise Longitudinal Assessment Trial
This study will evaluate the clinical efficacy and safety of udenafil, an orally administered, potent and selective inhibitor of PDE5, versus placebo for the treatment of adolescent subjects who have undergone the Fontan…
- Trial name
- FUEL (NCT02741115)
- Testing
- Udenafil
- Where
- 30 sites in United States, Canada and 1 more
- Volunteers
- 400 people
- Sponsor
- Mezzion Pharma Co. Ltd
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
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
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 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
Premature Ventricular Contraction
Efficacy and Safety of Sulcardine Sulfate Tablets in Patients With Premature Ventricular Contractions
Arrhythmia is a common disease that may be caused by various cardiovascular diseases. According to statistics, 500,000 people die of severe arrhythmia every year in China, In the United States, approximately 540,000 patients die…
- Trial name
- NCT01235156
- Where
- 2 sites in China
- Volunteers
- 36 people
- Sponsor
- Jiangsu Furui Pharmaceuticals Co., Ltd
Heart Failure
REGN5381 in Heart Failure Adult Participants With Elevated Pulmonary Capillary Wedge Pressure
This study is researching an experimental drug called REGN5381, further referred to as study drug. The study is focused on adult participants with heart failure that, in the opinion of the study doctor, have a clinical indication…
- Trial name
- NCT05353166
- Testing
- REGN5381
- Where
- Moldova
- Volunteers
- 59 people
- Sponsor
- Regeneron Pharmaceuticals
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
PremiCron Suture for Cardiac Valve Repair
The study is a voluntary study, initiated by B. Braun to collect clinical data for PremiCron® suture concerning its key indication.
- Trial name
- PremiValve (NCT04096859)
- Where
- 2 sites in Germany, Spain
- Volunteers
- 198 people
- Sponsor
- Aesculap AG
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
Healthy Participants
A Study to Evaluate the Effects of Mavacamten in Healthy Participants
The purpose of the study is to evaluate the effect between two different single doses of mavamten in healthy participants.
- Trial name
- NCT05719805
- Testing
- Mavacamten
- Where
- 2 sites in United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
The objective of this observational study is to investigate the long-term safety of autologous cardiac stem cells (JRM-001) administered to patients with single ventricle physiology.
- Trial name
- NCT07884318
- Where
- Japan
- Volunteers
- 40 people
- Sponsor
- Metcela Inc.
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
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
Aortic Stenosis Senile, Aortic Stenosis Symptomatic
Safety and Clinical Performance of the Next-Generation SAFESYNC Transcatheter Heart Valve in Patients With Severe Aortic Stenosis
The objective of this pivotal, prospective, multicenter, single-arm clinical trial is to evaluate the safety and clinical performance of the Next-Generation INOVARE® SAFESYNC Bioprosthetic Heart Valve, implanted via a…
- Conditions
- Aortic Stenosis Senile, Aortic Stenosis Symptomatic, Aortic Stenosis
- Trial name
- SAFESYNC NG (NCT07806409)
- Testing
- INOVARE® SAFESYNC Next-Generation Bioprosthetic Heart Valve
- Volunteers
- 40 people
- Sponsor
- Braile Biomedica Ind. Com. e Repr. Ltda.