Clinical trials: Echocardiography
Mitral Valve Regurgitation of Any Grade
Mitral Valve Regurgitation Quantification From 3D Color Doppler Ultrasound - Standard of Care Data Collection
The study primarily aims to collect standard of care clinical data in a wide spectrum of simple to complex mitral valve regurgitation (MVR) cases to validate a post-processing stand-alone software prototype (QFlow), developed by…
- Trial name
- NCT03286088
- Testing
- TransEsophageal Echocardiography and TransEsophageal Echocardiography, Cardiac Magnetics Resonance, MitraClip
- Where
- Belgium
- Volunteers
- 120 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Hypertension, Pulmonary
A Study for the Identification of Biomarker Signatures for Diagnosis of Pulmonary Hypertension (PH) in Participants at Low or Intermediate Probability of PH Undergoing Cardiac Magnetic Resonance Imaging
The primary purpose of this study is to estimate the percentage of participants in the population considered clinically as not having pulmonary hypertension (PH) that are positive for PH biomarker (micro ribonucleic acid [RNA])…
- Trial name
- NCT04480723
- Testing
- Blood Sample, Cardiac MRI
- Where
- 8 sites in Germany, United Kingdom
- Volunteers
- 86 people
- Sponsor
- Actelion
Cardiotoxicity, Cancer
Mazankowski Alberta Heart Institute (MAHI) EchoGo Discovery 1 Protocol
This study aims to compare conventionally acquired Left Ventricle Ejection Fraction (LVEF) and Global Longitudinal Strain (GLS) data to Artificial Intelligence (AI) driven automated processing of 2 dimensional contrast and 2…
- Trial name
- NCT04877899
- Testing
- EchoGo
- Where
- Canada
- Volunteers
- 250 people
- Sponsor
- Ultromics Ltd
Congenital Heart Disease
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious…
- Trial name
- NCT06392555
- Testing
- Device-Aided performances, Device-Unaided performances
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- BrightHeart
Cardiovascular Diseases, Arrhythmias, Cardiac
Intracardiac Echocardiography Catheter Supply-Chain Reliability and Clinical Access Study
The ICE-ACCESS study is a prospective observational study designed to evaluate how procurement reliability, distribution restrictions, supply-chain interruptions, and device availability affect access to intracardiac…
- Conditions
- Cardiovascular Diseases, Arrhythmias, Cardiac, Atrial Fibrillation
- Trial name
- ICE-ACCESS (NCT07788040)
- Testing
- Intracardiac Echocardiography Catheter
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Truway Health, Inc.
Symptomatic Heart Failure With Preserved Ejection Fraction (HFpEF)
AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
This is a Phase 2 dose-finding study in adult participants with symptomatic HFpEF.
- Trial name
- AMBER-HFpEF (NCT06793371)
- Testing
- CK-4021586 (150 mg, 300 mg, 450 mg, and 600 mg)
- Where
- 26 sites in United States
- Volunteers
- 60 people
- Sponsor
- Cytokinetics
Cardiac Disease
DEF-314 Better Accuracy in Ejection Fraction (EF) Assessment With DEFINITY
This is a Phase 3, prospective, open-label, multicenter study to evaluate Left Ventricular Ejection Fraction (LVEF) measurement accuracy and reproducibility of DEFINITY® contrast-enhanced and unenhanced echocardiography as…
- Trial name
- BENEFIT1 (NCT03571672)
- Testing
- DEFINITY
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Lantheus Medical Imaging
Acute Lung Injury
Study of Renin-angiotensin System in Mechanically Ventilated Subjects
The purpose of this study is to assess whether circulating Angiotensin (Ang) II and Ang (1-7) levels are associated with right ventricular (RV) dysfunction in mechanically ventilated subjects.
- Trial name
- NCT03212690
- Testing
- Local standard of care, Mechanical ventilation
- Where
- 2 sites in France
- Volunteers
- 57 people
- Sponsor
- GlaxoSmithKline
Heart Failure With Preserved Ejection Fraction, Heart Failure With Mid Range Ejection Fraction
Extended IASD Investigation: REDUCE LAP-HF IV
Multicenter, Prospective, Open Label, Single Arm, Clinical Trial. The primary objective of this clinical trial is to further evaluate the safety and clinical efficacy of the IASD System II in symptomatic heart failure patients…
- Trial name
- NCT04632160
- Testing
- IASD System II
- Sponsor
- Corvia Medical
Structural Heart Diseases, Atrial Septal Defect
Cardiac Interventional ICE Imaging Trial
The INTELICE trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. It aims to compare a novel intracardiac echography (ICE) catheter and combined ultrasound system with existing commercial ones.
- Conditions
- Structural Heart Diseases, Atrial Septal Defect, Patent Foramen Ovale, Arrhythmias, Cardiac
- Trial name
- INTELICE (NCT06344494)
- Testing
- Arch EchoTM Intracardiac Ultrasound catheter and ultrasound system, SOUNDSTAR 3D Diagnostic Ultrasound catheter and ACUSON P500 system
- Where
- 4 sites in China
- Volunteers
- 130 people
- Sponsor
- ICE Intelligent Healthcare Co., Ltd
Mitral Regurgitation
SQ-Kyrin TMVr FIM Study
A feasibility study to evaluate the effectiveness and safety of the SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System for the treatment of moderate-to-severe mitral regurgitation in patients with high surgical risk.
- Trial name
- NCT05040074
- Testing
- SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Coronary Artery Disease
Evaluation of Safety and Efficacy of Lumason/SonoVue in Subjects Undergoing Pharmacologic Stress BR1-142
The purpose of this study was to assess the safety and efficacy of Lumason-enhanced dobutamine stress echo (DSE) in subjects having a suboptimal left ventricular endocardial border delineation (LV EBD) at rest and who were…
- Trial name
- NCT02552238
- Testing
- Lumason
- Where
- 13 sites in United States, Belgium and 2 more
- Volunteers
- 174 people
- Sponsor
- Bracco Diagnostics, Inc
Heart Failure
Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN
BIOWOMEN is a study designed to compare the Cardiac Resynchronization Therapy (CRT) response rate in a Heart Failure (HF) population with an equal distribution of men and women.
- Trial name
- BIOWOMEN (NCT02344420)
- Testing
- Echocardiography, Minnesota Living Heart Failure Questionnaire (MLHF), Six minute walk test
- Where
- Spain
- Volunteers
- 494 people
- Sponsor
- Biotronik SE & Co. KG
Tricuspid Regurgitation
Feasibility Study of Dragonfly System for Severe Tricuspid Regurgitation
The study is designed to assess the feasibility of the DragonFly transcatheter mitral valve clamping system for the treatment of symptomatic severe tricuspid regurgitation.
- Trial name
- NCT04921605
- Testing
- DragonFly transcatheter mitral valve clamping system
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Hangzhou Valgen Medtech Co., Ltd
Atrial Fibrillation, Left Atrial Appendage Closure
Data Collection for Echocardiography-Based Software Assessment
This is a prospective, observational study collecting data from routine clinical care. The information gathered will be used to support the evaluation of a software-based tool.
- Conditions
- Atrial Fibrillation, Left Atrial Appendage Closure, Cardiovascular Diseases
- Trial name
- NCT07126600
- Testing
- No investigational intervention administered
- Where
- 6 sites in United States
- Volunteers
- 100 people
- Sponsor
- Anumana, Inc.
Heart Transplant Rejection
Surveillance HeartCare® Outcomes Registry
This is an observational registry to assess the clinical utility of surveillance using HeartCare testing services, in association with clinical care of heart transplant recipients.
- Trial name
- SHORE (NCT03695601)
- Testing
- Standard of Care
- Where
- 67 sites in United States
- Volunteers
- 2,743 people
- Sponsor
- CareDx
Mitral Regurgitation Functional, Mitral Valve Disease
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
To evaluate the feasibility and safety of the Millipede Transcatheter Annuloplasty Ring System in subjects with functional mitral regurgitation
- Conditions
- Mitral Regurgitation Functional, Mitral Valve Disease, Cardiovascular Diseases
- Trial name
- NCT04147884
- Testing
- Millipede Transcatheter Annuloplasty Ring System (Millipede System)
- Where
- 4 sites in United States, Australia
- Volunteers
- 4 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Cardiac Arrhythmia
Evaluation of the BIOTRONIK AutoAdapt Algorithm for Continuous Automatic Adaptive Cardiac Resynchronization
BIO|Adapt study is designed to provide evidence for the clinical benefit of the CRT AutoAdapt feature. This feature provides continuous adaptation of AV delay and biventricular pacing modality.
- Conditions
- Heart Failure, Cardiac Arrhythmia, Left Ventricular Dysfunction
- Trial name
- BIO|Adapt (NCT04774523)
- Testing
- Echo-based assessment of the acute hemodynamic effect of the CRT AutoAdapt feature., Echocardiography AV optimization, Echocardiography
- Where
- Spain
- Volunteers
- 198 people
- Sponsor
- Biotronik SE & Co. KG
Coronary Artery Disease
Phase 3 Imaging and Safety Study of AI-700 in Patients With Suspected Coronary Artery Disease Undergoing SPECT Imaging
This study was designed to evaluate the ability of AI-700-enhanced rest-stress echocardiography to detect coronary artery disease (CAD) in patients with suspected ischemic heart disease who are indicated for single-photon…
- Trial name
- NCT00156793
- Testing
- AI-700 contrast-enhanced echocardiography
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Acusphere
Mitral Valve Insufficiency, Cardiac Valve Annuloplasty
REPAIR - transcatheteR rEPair of mitrAl Insufficiency With caRdioband System
The Cardioband Transcatheter System (Cardioband) is indicated for the treatment of secondary (functional) mitral regurgitation (FMR).
- Conditions
- Mitral Valve Insufficiency, Cardiac Valve Annuloplasty, Mitral Valve Annuloplasty, Cardiovascular Diseases
- Trial name
- REPAIR (NCT02703311)
- Testing
- Cardioband
- Where
- 10 sites in France, Germany and 1 more
- Volunteers
- 11 people
- Sponsor
- Edwards Lifesciences