Clinical trials: Single Ventricle
Aortic Valve Stenosis
DEFLECT II: A Study to Evaluate the Safety and Performance of the TriGuard™HDH in Patients Undergoing TAVR
Pilot study enrolling up to 12 patients at a single investigational site in the Netherlands. Patients for TAVR will be enrolled to receive the Embolic Deflection Device throughout the duration of the TAVR procedure.
- Trial name
- NCT02073851
- Testing
- TriGuard™HDH
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Keystone Heart
Heart Failure
Phase IIb Safety and Efficacy Study of Different Oral Doses 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 Chronic Kidney Disease Alone
To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was safe and can help the well-being of patients with worsening chronic heart failure and either type II diabetes with or without chronic…
- Trial name
- ARTS-HF (NCT01807221)
- Testing
- Finerenone (BAY94-8862), Inspra (eplerenone)
- Where
- 172 sites in United States, Australia and 23 more
- Volunteers
- 1,066 people
- Sponsor
- Bayer
Chronic Obstructive Pulmonary Disease, COPD
Effect of QVA149 (Indacaterol Maleate/Glycopyrronium Bromide) on Cardiac Function in COPD Patients
This mechanistic study is a single-center, randomized, double-blind, placebo-controlled, cross-over study to evaluate the effect of dual bronchodilation with QVA149 on cardiac and lung function parameters in hyperinflated COPD…
- Trial name
- CLAIM (NCT02442206)
- Testing
- QVA149
- Where
- Germany
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Aortic Valve Stenosis
Valvosoft First-In-Human 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-Human
- Trial name
- NCT04665596
- Testing
- Ultrasound treatment
- Where
- Serbia
- Volunteers
- 10 people
- Sponsor
- Cardiawave SA
Functional Single Ventricle Heart Disease
A Extension Study of Udenafil in Adolescents
This study is a 12-month (52 week) safety extension study to supplement the FUEL Phase III clinical trial to provide safety information regarding the long-term use of udenafil in adolescents with single ventricle congenital heart…
- Trial name
- FUELExten (NCT03013751)
- Testing
- Udenafil
- Where
- 24 sites in United States, Canada and 1 more
- Volunteers
- 301 people
- Sponsor
- Mezzion Pharma Co. Ltd
Heart Failure (HF)
A Study of Ivabradine in African-American/ Black Subjects With Heart Failure and Left Ventricular Systolic Dysfunction.
This study is a prospective, open-label, single-arm intervention study in African-American/Black subjects with heart failure and reduced ejection fraction (HFrEF).
- Trial name
- NCT03456856
- Testing
- Ivabradine
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Amgen
Coronary Artery Disease
CorVad Percutaneous Ventricular Assist System Study
This study aims to evaluate the safety and effectiveness of the CorVad Percutaneous Ventricular Assist System for short-term ventricular support during high-risk percutaneous coronary intervention (HRPCI) in non-emergent…
- Trial name
- NCT06198998
- Testing
- CorVad Percutaneous Ventricular Assist System
- Where
- 12 sites in China
- Volunteers
- 120 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Aortic Valve Stenosis
The SAPIEN 3 Ultra System in Intermediate Risk Patients With Symptomatic, Severe Aortic Stenosis
This study will confirm the procedural safety and performance of the SAPIEN 3 Ultra System in subjects with severe, calcific AS who are at intermediate operative risk for standard aortic valve replacement.
- Trial name
- NCT03471065
- Testing
- SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV
- Where
- 6 sites in Canada, United Kingdom
- Volunteers
- 100 people
- Sponsor
- Edwards Lifesciences
Refractory Heart Failure
Corheart 6 LVAS Study
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.
- Trial name
- NCT05876000
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 53 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
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.
Heart Failure, Ventricular Dysfunction, Left
Evaluation of Heart Failure Treatment Guided by N-terminal Pro B-type Natriuretic Peptide (NTproBNP) vs Clinical Symptoms and Signs Alone
The purpose is to study if HF treatment guided by NTproBNP in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with HF and left ventricular systolic…
- Trial name
- NCT00391846
- Testing
- Captopril, Enalapril, Lisinopril
- Where
- 39 sites in Sweden
- Volunteers
- 252 people
- Sponsor
- AstraZeneca
Class I or II Indication for Implantation of a Single Chamber Ventricular Pacemaker According to ACC/AHA/HRS 2001 Guidelines and Any National Guidelines
Micra Transcatheter Pacing Study
The purpose of this clinical study is to evaluate the safety and efficacy of the Micra Transcatheter Pacing System and to assess long term performance.
- Trial name
- NCT02004873
- Testing
- Micra Pacemaker Implant
- Where
- 56 sites in United States, Australia and 17 more
- Volunteers
- 744 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Prospective Study of the BioVentrix PliCath HF™ System for the Treatment of Ischemic Cardiomyopathy
The purpose of the study is to determine the safety, and feasibility of a device, which enables LV volume and radius reduction through scar exclusion in patients whose systolic HF is due to ischemic cardiomyopathy.
- Trial name
- CONFIGURE-HF (NCT01568138)
- Testing
- PliCath HF System
- Where
- 4 sites in Latvia, Lithuania and 2 more
- Volunteers
- 26 people
- Sponsor
- BioVentrix
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 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
Pulmonary Arterial Hypertension
REPAIR: Right vEntricular Remodeling in Pulmonary ArterIal hypeRtension
The study evaluates the effect of macitentan on right ventricular and hemodynamic properties in patients with symptomatic pulmonary arterial hypertension. Patients are treated with macitentan for 1 year.
- Trial name
- REPAIR (NCT02310672)
- Testing
- Macitentan
- Where
- 41 sites in United States, Australia and 10 more
- Volunteers
- 89 people
- Sponsor
- Actelion
Left Ventricular Dysfunction, Ventricular Dysfunction
Low Ejection Fraction in Single Lead ECG
The purpose of this research is to prospectively test and validate the single-lead Low EF algorithm in outpatients in order to test the performance of a single-lead ECG based algorithm to identify people with decreased left…
- Conditions
- Left Ventricular Dysfunction, Ventricular Dysfunction, Heart Diseases, Cardiovascular Diseases
- Trial name
- NCT05010655
- Testing
- Use of Eko DUO Electronic Stethoscope
- Where
- 2 sites in United States
- Volunteers
- 1,935 people, healthy volunteers welcome
- Sponsor
- Eko Devices, Inc.
Aortic Stenosis
VitaFlow™ II 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™ II Transcatheter Aortic Valve System for the treatment of severe aortic stenosis.
- Trial name
- NCT04414878
- Testing
- VitaFlow™ II Transcatheter Aortic Valve System
- Where
- 4 sites in China
- Volunteers
- 145 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
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
Cardiogenic Shock
Catheter-Oriented Unloading and Recovery With a Left Ventricular Assist Gear: Efficacy in Post Cardiotomy Cardiogenic Shock
This study is a prospective, multicenter, single-arm clinical trial conducted in China to evaluate the efficacy and safety of a novel left ventricular assist device, SynFlow Duro system, manufactured by ForQaly Medical in the…
- Trial name
- COURAGE (NCT07560085)
- Testing
- SynFlow Duro
- Where
- 2 sites in China
- Volunteers
- 60 people
- Sponsor
- ForQaly Medical (Shanghai) Co., Ltd