Clinical trials: Functional Cardiac Disorder
Tricuspid Regurgitation Functional
Acute Safety and Efficacy of the Pivot Bridge System for Functional Tricuspid Regurgitation
The purpose of this clinical trial is as follows. To assess the safety of the investigational medical device "Pivot Bridge" in participants aged 18 years or older with massive or greater functinal tricuspid regurgitation (TR) who…
- Trial name
- Pivot TR (NCT07385625)
- Testing
- Pivot Bridge
- Where
- 4 sites in South Korea
- Volunteers
- 20 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Heart Failure
Clinical Evaluation of the Physiological Diagnosis Function in the PARADYM CRT Device
This clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.This trial is being performed in order to demonstrate the sensivity of the diagnostic feature "Physiological Diagnostic" (PhD).
- Trial name
- CLEPSYDRA (NCT02167789)
- Testing
- Paradym CRT 8770
- Where
- 50 sites in United States, Canada and 7 more
- Volunteers
- 520 people
- Sponsor
- LivaNova
Functional Mitral Regurgitation
Safety and Effectiveness Study of SQ-Kyrin TMVr System for Functional Mitral Regurgitation
To verify the safety and effectiveness of transcatheter mitral valve clip delivery system and steerable guide catheter produced by Shanghai Shenqi Medical Technology Co., Ltd.
- Trial name
- NCT05988450
- Testing
- SQ-Kyrin Transcatheter Mitral Valve Repair System
- Where
- China
- Volunteers
- 125 people
- Sponsor
- Shanghai Shenqi Medical Technology Co., Ltd
Coronary Artery Disease, ST-segment Elevation Myocardial Infarction
Post-Marketing Safety Study in ST-Segment Elevation Myocardial Infarction (STEMI) Participants Undergoing Primary Percutaneous Coronary Intervention (PCI) Procedure With VISIPAQUE® as the Contrast Medium
The purpose of this study is to prospectively observe the incidence rate of acute kidney injury (AKI), major adverse renal and cardiovascular events (MARCE) in participants who were diagnosed with ST-segment elevation myocardial…
- Trial name
- NCT03671603
- Testing
- Iodixanol
- Where
- 36 sites in China, South Korea
- Volunteers
- 2,755 people
- Sponsor
- GE Healthcare
Amyloidosis
Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698
The study is intended to evaluate whether monthly repeated courses of administration of GSK2315698 followed by GSK2398852 is associated with a reduction in cardiac amyloid load in patients with cardiac amyloidosis, monitored by…
- Trial name
- NCT03044353
- Testing
- GSK2315698 (CPHPC), GSK2398852 (anti-SAP mAb)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 7 people
- Sponsor
- GlaxoSmithKline
Congestive Heart Failure
Autonomic Neural Regulation Therapy to Enhance Myocardial Function in Heart Failure (ANTHEM-HF) Study
The ANTHEM-HF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure.
- Trial name
- ANTHEM-HF (NCT01823887)
- Testing
- Vagus Nerve Stimulation (VNS)
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Cyberonics, Inc.
Myocardial Infarction, Myocardial Infarction, Acute
BIO monitorinG in Patients With Preserved Left ventricUlar Function AfteR Diagnosed Myocardial Infarction
The BIO|GUARD-MI study investigates whether continuous arrhythmia monitoring and the consequent treatment after detected arrhythmias in patients after myocardial infarction with preserved cardiac function, but other risk factors…
- Conditions
- Myocardial Infarction, Myocardial Infarction, Acute, Myocardial Infarction Old
- Trial name
- BIO-GUARD-MI (NCT02341534)
- Testing
- BioMonitor
- Where
- 59 sites in United States, Australia and 12 more
- Volunteers
- 802 people
- Sponsor
- Biotronik SE & Co. KG
Cardiomyopathy, Hypertrophic, Cardiomyopathy, Hypertrophic, Familial
Open-Label Study of Perhexiline in Patients With Hypertrophic Cardiomyopathy and Moderate to Severe Heart Failure
The purpose of this study is to evaluate the effect of perhexiline on exercise performance (efficacy) and safety in patients with hypertrophic cardiomyopathy and moderate-to-severe heart failure following dosing for 16 weeks.
- Trial name
- NCT02862600
- Testing
- Perhexiline, Use of bioanalytical assay to monitor plasma levels of perhexiline
- Where
- 11 sites in United States
- Volunteers
- 35 people
- Sponsor
- Heart Metabolics Limited
Fabry Disease
Safety and Efficacy Study of Several Replagal Dosing Regimens on Cardiac Function in Adults With Fabry Disease
The purpose of this study is to compare the safety and effectiveness of various doses of Replagal in patients with cardiomyopathy due to Fabry disease.
- Trial name
- NCT00864851
- Testing
- Replagal
- Where
- 12 sites in United States, Australia and 6 more
- Volunteers
- 44 people
- Sponsor
- Shire
Severe Functional Mitral Regurgitation and Heart Failure
Feasibility of the AccuCinch® System for Left Ventricular Reshaping of the Mitral Apparatus to Reduce Functional Mitral Regurgitation and Improve Left Ventricular Function
To assess the safety and performance of the GDS Accucinch System when used percutaneously to reduce functional mitral regurgitation.
- Trial name
- LVRECOVER (NCT02153892)
- Testing
- GDS Accucinch System
- Where
- Australia
- Volunteers
- 2 people
- Sponsor
- Ancora Heart, Inc.
Functional Mitral Regurgitation, Atrial Fibrillation
An Initial Evaluation of the Carillon Mitral Contour System for Treatment of Atrial Function Mitral Regurgitation
The objective of this prospective, multi-center trial is to assess the effectiveness of the CARILLON Mitral Contour System in treating patients with moderate-to-severe atrial functional mitral regurgitation (aFMR)
- Conditions
- Functional Mitral Regurgitation, Atrial Fibrillation, Atrial Functional Mitral Regurgitation
- Trial name
- AFIRE (NCT04529928)
- Testing
- Carillon Mitral Contour System
- Where
- 2 sites in Australia, Greece
- Volunteers
- 4 people
- Sponsor
- Cardiac Dimensions Pty Ltd
Bradycardia, Remote Monitoring
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.
- Trial name
- CALLIOPE (NCT05165095)
- Testing
- Pacemaker implantation
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 206 people
- Sponsor
- MicroPort CRM
Atherosclerosis, Inflammatory Activity in Coronary Arteries
Exploratory Study of Coronary Flow Reserve Measurements, a Non-Invasive Method for Coronary Function Measurements
The aim of this study is to investigate whether the non-invasive ultrasound method for assessment of coronary blood flow, transthoracic Doppler echocardiography-coronary flow reserve (TTDE-CFR), can be used to measure drug…
- Trial name
- NCT00783042
- Testing
- Rosuvastatin
- Where
- Sweden
- Volunteers
- 80 people
- Sponsor
- AstraZeneca
Human Immunodeficiency Virus, Ischemic Heart Disease
Omacor and Cardiovascular Risk Factors in HIV Patients on HAART Treatment
The purpose of this study is to evaluate the effect of Omacor 4g/day on blood lipid parameters and on the function and stiffness of blood vessels in HIV infected patients on Antiretroviral Therapy (HAART)
- Trial name
- NCT00296153
- Testing
- Omega-3-acid ethyl esters 90
- Where
- Denmark
- Volunteers
- 51 people
- Sponsor
- Pronova BioPharma
Anemia
(ACORD Study) - A Study of NeoRecormon (Epoetin Beta) in Patients With Early Diabetic Nephropathy
This study will assess the effect of anemia correction with NeoRecormon on cardiac structure and function in patients with early diabetic nephropathy.
- Trial name
- NCT00354341
- Testing
- Epoetin beta
- Where
- 63 sites in Austria, Brazil and 15 more
- Volunteers
- 170 people
- Sponsor
- Hoffmann-La Roche
Heart Failure
The Effects of Sacubitril/Valsartan on Cardiac Oxygen Consumption and Efficiency of Cardiac Work in Heart Failure Patients
This is a phase IV, prospective, randomized, double-blind, double-dummy, parallel-group study. The study assessed the effects of 6 weeks of stable sacubitril/valsartan therapy, as compared with valsartan therapy, on the…
- Trial name
- TurkuPET (NCT03300427)
- Testing
- sacubitril/valsatran, valsartan
- Where
- Finland
- Volunteers
- 55 people
- Sponsor
- Novartis Pharmaceuticals
Cardiac Surgery
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute…
- Trial name
- NCT04654221
- Testing
- mGFR by iohexol clearance
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Quark Pharmaceuticals
Heart Failure, Decompensated Heart Failure
A Dose Ranging Phase IIa Study of 6 Hour Intravenous Dosages of CXL-1427 in Patients Hospitalized With Heart Failure
A randomized, double-blinded, placebo-controlled study of continuous 6-hour IV infusions of CXL-1427 in hospitalized patients with systolic heart failure.
- Conditions
- Heart Failure, Decompensated Heart Failure, Acute Heart Failure
- Trial name
- NCT02157506
- Testing
- CXL-1427
- Where
- 35 sites in United States, Germany and 3 more
- Volunteers
- 70 people
- Sponsor
- Bristol-Myers Squibb
Degenerative Mitral Valve Disease, Mitral Regurgitation
Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve…
- Conditions
- Degenerative Mitral Valve Disease, Mitral Regurgitation, Mitral Insufficiency, Functional Mitral Regurgitation
- Trial name
- CLASP IID/IIF (NCT03706833)
- Testing
- Edwards PASCAL System, Abbott Mitraclip System
- Where
- 81 sites in United States, Canada and 2 more
- Volunteers
- 1,247 people
- Sponsor
- Edwards Lifesciences
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.