Clinical trials: Heart; Disease, Functional
Mitral Valve (MV) Regurgitation
A Prospective, Multicenter, Single-Arm Study to Support the Clinical Evidence Base for MRace as a Treatment Option for FMR Patients With Complex M-TEER Anatomies (AU)
A pilot study to evaluate the safety and performance of the MRace System to treat severe mitral regurgitation and to gather data on its performance thereby providing guidance for future clinical development.
- Trial name
- ACCESS-MR (AU) (NCT07757698)
- Testing
- Transcatheter mitral valve repair
- Volunteers
- 15 people
- Sponsor
- Polares Medical SA
Coronary Artery Disease, Ischemic Heart Disease
Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting
Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing…
- Trial name
- DEFINE GPS (NCT04451044)
- Testing
- Philips SyncVision system with Philips pressure wires, standard of care angiographically-guided PCI
- Where
- 84 sites in United States, Australia and 16 more
- Volunteers
- 3,212 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Myocardial Failure, Cardiac Failure
A Study of Experimental Medication BMS-986231 in Patients With Different Levels of Kidney Function
The purpose of this study is to investigate experimental medication BMS-986231 in patients with different levels of kidney function.
- Conditions
- Myocardial Failure, Cardiac Failure, Congestive Heart Failure, Kidney Failure
- Trial name
- NCT03332186
- Testing
- BMS-986231
- Where
- 3 sites in Czechia, Poland
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Atrial Fibrillation
Repeatable Evaluation of Functional Intra-procedural Signals for Effect in Pulsed Field Ablation REFINE-PFA
The study is a prospective, exploratory observational study with the ECGenius® System and the PFAnalyzer software module in PFA cases using the FaraPulse PFA system.
- Trial name
- REFINE-PFA (NCT07275151)
- Testing
- Pulmonary vein isolation ablation
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- CathVision ApS
Mitral Valve Insufficiency, Mitral Valve Regurgitation
EVEREST II Pivotal Study High Risk Registry (HRR)
Prospective, multi-center, single arm registry. Clinical follow-up at discharge, 30 days, 6, 12, 18 and 24, months, and 3, 4 and 5 years.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Regurgitation, Mitral Valve Incompetence, Mitral Regurgitation
- Trial name
- HRR (NCT01940120)
- Testing
- Percutaneous mitral valve repair using MitraClip implant
- Where
- 2 sites in United States
- Volunteers
- 78 people
- Sponsor
- Abbott Medical Devices
Chronic Heart Failure
A Study to Evaluate the Effects of 4 Weeks Treatment With Subcutaneous Elamipretide on Left Ventricular Function in Subjects With Stable Heart Failure With Preserved Ejection Fraction
This is a multi-center, randomized, double-blind, placebo-controlled study in subjects with stable heart failure with preserved ejection fraction (HFpEF) to evaluate the effects of 4 weeks treatment with subcutaneous MTP-131…
- Trial name
- NCT02814097
- Testing
- elamipretide
- Where
- 9 sites in Germany, Serbia
- Volunteers
- 46 people
- Sponsor
- Stealth BioTherapeutics Inc.
Heart Failure, Congestive
A Study of Iron Oligosaccharide in CHF Patients
The purpose of this study is to determine the safety profile of iron oligosaccharide in patients with congestive heart failure with a need for parenteral iron.
- Trial name
- NCT00537186
- Testing
- Iron oligosaccharide
- Where
- Denmark
- Volunteers
- 20 people
- Sponsor
- Pharmacosmos A/S
Coronary Artery Disease
Study of the Vascular Effects of Serelaxin
This was a mechanistic study in patients with coronary artery disease on the effects of Serelaxin on micro- and macrovascular function.
- Trial name
- NCT01979614
- Testing
- Serelaxin
- Where
- 3 sites in United Kingdom
- Volunteers
- 58 people
- Sponsor
- Novartis Pharmaceuticals
Obesity
Research Study to Investigate How Well Semaglutide Works in People Living With Heart Failure and Obesity
This study will look at how the participants daily life is affected by their heart failure. The study will also look at the change in participants body weight from the start to the end of the study.
- Trial name
- STEP-HFpEF (NCT04788511)
- Testing
- Semaglutide
- Where
- 146 sites in United States, Argentina and 11 more
- Volunteers
- 529 people
- Sponsor
- Novo Nordisk A/S
Functional Tricuspid Regurgitation, Heart Valve Diseases
Early Feasibility Study of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
The primary objective of the study is to generate feasibility safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from moderate to severe functional tricuspid regurgitation with…
- Conditions
- Functional Tricuspid Regurgitation, Heart Valve Diseases, Tricuspid Valve Insufficiency
- Trial name
- NCT03632967
- Testing
- Tricinch Coil System Implantation
- Where
- 9 sites in United States
- Volunteers
- 7 people
- Sponsor
- 4Tech Cardio Ltd.
Functional Mitral Regurgitation, Heart Failure
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
- Trial name
- NCT02471664
- Testing
- Mitral Loop Cerclage Annuloplasty
- Where
- 2 sites in United States, South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Congestive Heart Failure
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction
The ANTHEM-HFpEF 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 with preserved and…
- Trial name
- NCT03163030
- Testing
- Vagus Nerve Stimulation (VNS)
- Where
- India
- Volunteers
- 52 people
- Sponsor
- Cyberonics, Inc.
Congestive Heart Failure
Safety and Efficacy of Furosemide 40mg + Amiloride Hydrochloride 10mg to Reduct Edema
The study consists in two treatment groups, one group will receive Diurisa® (furosemide 40 mg + amiloride chloride 10 mg) and the other one will receive furosemide 40 mg (Lasix®)
- Trial name
- NCT01210365
- Testing
- Diurisa®, Lasix ®
- Where
- 4 sites in Brazil
- Volunteers
- 27 people
- Sponsor
- Eurofarma Laboratorios S.A.
Coronary Artery Disease, Cardiovascular Diseases
Functional Diagnostic Accuracy of Quantitative Flow Ratio in Tandem Lesions and Virtual Stenting
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. Virtual stent implantation technique combined with QFR was recently developed to predict the functional significance…
- Conditions
- Coronary Artery Disease, Cardiovascular Diseases, Myocardial Ischemia, Arterial Occlusive Diseases
- Trial name
- FORTRESS (NCT03405506)
- Testing
- Quantitative Flow Ratio (QFR)
- Where
- China
- Volunteers
- 308 people
- Sponsor
- Pulse Medical Imaging Technology (Shanghai) Co., Ltd
Mitral Valve Regurgitation (Degenerative or Functional)
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system
- Trial name
- NCT05263375
- Testing
- Innovalve TMVR system
- Sponsor
- Innovalve Bio Medical Ltd.
Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency
Early Feasibility of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) Also Known as TriAlign™.
The purpose of this study is to assess the early safety and performance of the Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) for the treatment of symptomatic chronic functional tricuspid regurgitation (FTR).
- Conditions
- Chronic Symptomatic Functional Tricuspid Regurgitation, Tricuspid Valve Insufficiency, Heart Valve Disease
- Trial name
- SCOUT (NCT02574650)
- Testing
- Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)
- Where
- 11 sites in United States
- Volunteers
- 30 people
- Sponsor
- Mitralign, Inc.
Mitral Valve Regurgitation
Mitralign Percutaneous Annuloplasty System for Chronic Functional Mitral Valve Regurgitation
The purpose of this study is to test the safety and device performance of the Mitralign system ("MPAS") to treat functional mitral valve regurgitation.
- Trial name
- ALIGN (NCT01740583)
- Testing
- percutaneous annuloplasty
- Where
- 8 sites in Colombia, France and 2 more
- Volunteers
- 50 people
- Sponsor
- Mitralign, Inc.
Atrial Fibrillation
Is Endothelial Function a Predictor of Successful Ablation Therapy Provided to Patients With Atrial Fibrillation?
The purpose of this study is to assess whether normal endothelial function in patients with Atrial Fibrillation undergoing ablation procedure increases the chances of a favorable clinical outcome and maintaining sinus rhythm…
- Trial name
- NCT02129842
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 150 people
- Sponsor
- Itamar-Medical, Israel
Hypertension, Coronary Arteriosclerosis
SAFE-CRP: Structural Alterations and Function of Endothelium in Cardiovascular Risk Patients
The aim of this trial is to evaluate the efficacy and safety of telmisartan 80 mg administered once daily in patients with documented coronary artery disease (CAD) and a probably cardiovascular risk profile concerning the…
- Trial name
- NCT00274105
- Testing
- telmisartan
- Where
- 2 sites in Germany
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Mitral Regurgitation
Carillon Mitral Contour System for Treatment of Exercise Induced Functional Mitral Regurgitation
Evaluate the hemodynamic and anatomical effect of the commercially available CMCS system within its current indication on a subset of patients with exercise induced mitral regurgitation.
- Trial name
- EXERCISE FMR (NCT05040451)
- Testing
- Carillon Mitral Contour System
- Sponsor
- Cardiac Dimensions Pty Ltd