Clinical trials: Impaired Left Ventricular Function
Heart Failure With Reduced Ejection Fraction
First in Humans to Evaluate Collagen Patches With Stem Cells in Patients With Ischemic Left Ventricular Dysfunction
It´s a first open-label trial in humans to evaluate the safety and efficacy of epicardial delivery of collagen patches with adipose-derived stem cells in patients with ischemic heart disease and left ventricular dysfunction that…
- Trial name
- CARDIOMESH (NCT03746938)
- Testing
- VB-C01
- Where
- 2 sites in Spain
- Volunteers
- 10 people
- Sponsor
- Viscofan
Myocardial Infarction
Allogeneic Heart Stem Cells to Achieve Myocardial Regeneration
The purpose of this study is to determine whether Allogeneic Cardiosphere-Derived Cells (CAP-1002) is safe and effective in decreasing infarct size in patients with a myocardial infarction.
- Trial name
- ALLSTAR (NCT01458405)
- Testing
- CAP-1002 Allogeneic Cardiosphere-Derived Cells
- Where
- 32 sites in United States
- Volunteers
- 135 people
- Sponsor
- Capricor Inc.
Coronary Artery Disease
A Study of Anginera In Patients Undergoing Coronary Artery Bypass Graft (CABG) Surgery
This is a first in man, Phase I safety study of Anginera in adults with Left Ventricular Dysfunction (LVD) and Reversible Myocardial Ischemia undergoing a CABG procedure.
- Trial name
- NCT00364390
- Testing
- Anginera, a human tissue replacement therapy
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Theregen, Inc.
Acute Myocardial Infarction, Early Left Ventricular Dysfunction
Alster Stem Cells - Intramyocardial Stem Therapy
Study to assess the efficacy of intramyocardial bone marrow derived mononuclear cell therapy concerning left ventricular ejection fraction as measured by echocardiography.
- Trial name
- NCT00939042
- Testing
- Percutaneous Coronary Intervention, BMNC therapy
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Asklepios proresearch
Left Ventricular Dysfunction, Heart Failure
Detection of Heart Conditions Using Artificial Intelligence
The purpose of this study is to evaluate how Eko AI performs in the real world, front-line setting where the availability of sophisticated, expensive diagnostic tools is limited, and where there is a premium on detecting VHD…
- Trial name
- NCT04933890
- Testing
- Use of Eko DUO electronic stethoscope
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Eko Devices, Inc.
Pulmonary Hypertension
Clinical Study to Evaluate the Safety and Tolerability of Macitentan in Subjects With Combined Pre- and Post-capillary Pulmonary Hypertension (CpcPH) Due to Left Ventricular Dysfunction
Study to evaluate if macitentan is safe and tolerable enough to be used for treatment of subjects with combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction.
- Trial name
- MELODY-1 (NCT02070991)
- Testing
- Macitentan
- Where
- 32 sites in United States, Austria and 9 more
- Volunteers
- 63 people
- Sponsor
- Actelion
Heart Failure
REsynchronization reVErses Remodeling in Systolic Left vEntricular Dysfunction (REVERSE)
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00271154
- Testing
- Cardiac Resynchronization Therapy (CRT) Device or Implantable Cardioverter Defibrillator (ICD) with CRT
- Where
- 65 sites in United States, Austria and 13 more
- Volunteers
- 684 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Ventricular Dysfunction, Myocardial Infarction
Autologous Bone Marrow Transplanted Via Transendocardial Catheter to Chronic Myocardial Infarct Border Zone
The object of this open-labeled, uncontrolled pilot study was to investigate the safety and feasibility of percutaneously transplanting autologous bone marrow (ABM) cells into the myocardium using the helical needle…
- Trial name
- TABMMI (NCT00507468)
- Testing
- Transendocaridal Transplantation of Autologous Bone Marrow
- Where
- 2 sites in Argentina
- Volunteers
- 20 people
- Sponsor
- BioCardia, Inc.
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
Systolic Left Ventricular Dysfunction
Performance and Safety of the Cardiac Microcurrent Therapy System
Patients with idiopathic dilative cardiomyopathy who have systolic left ventricular dysfunction (NYHA III - IV) despite adequate therapy according to treatment guidelines of heart failure and who have a baseline left ventricular…
- Trial name
- C-MIC-II (NCT04662034)
- Testing
- CMIC, Standard of Care (SOC)
- Where
- 20 sites in Bosnia and Herzegovina, Bulgaria and 9 more
- Volunteers
- 70 people
- Sponsor
- Berlin Heals GmbH
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Hemodynamic and Echocardiographic Assessment of Riociguat Effects on Myocardial Wall Contractility and Relaxation Kinetics
The aim of this study is to assess whether oral Riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction
- Trial name
- HEARTWORK (NCT01065051)
- Testing
- Riociguat (Adempas, BAY63-2521)
- Where
- 2 sites in United States
- Volunteers
- 1 people
- Sponsor
- Bayer
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
Mitral Valve Regurgitation, Left Ventricular Dysfunction
RESTOR-MV: Randomized Evaluation of a Surgical Treatment for Off-Pump Repair of the Mitral Valve
The purpose of this prospective, randomized, multi-center, pivotal trial is to compare the safety and effectiveness of the off-pump, closed heart Coapsys System (Myocor, Inc.) to open surgical repair of the mitral valve using an…
- Conditions
- Mitral Valve Regurgitation, Left Ventricular Dysfunction, Heart Failure
- Trial name
- NCT00120276
- Testing
- Less invasive mitral valve repair
- Where
- 10 sites in United States
- Volunteers
- 250 people
- Sponsor
- Myocor
Acute Myocardial Infarction
IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction
Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III).
- Trial name
- NCT00157768
- Testing
- Implantable cardioverter defibrillator
- Where
- Netherlands
- Volunteers
- 900 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Post MI Left Ventricular Dysfunction
IdeNtifying High riSk Patients Post Myocardial Infarction With REduced Left Ventricular Function Using External Loop Recorders (INSPIRE-ELR Study)
The purpose of the INSPIRE-ELR study is to characterize arrhythmias in post MI low EF (≤35%) patients in the acute phase (at discharge from hospital after index MI) and chronic phase (at 8-10 weeks after index MI) and to…
- Trial name
- INSPIRE-ELR (NCT01995552)
- Testing
- External Loop Recorder
- Where
- India
- Volunteers
- 250 people
- Sponsor
- Medtronic BRC
Heart Failure
The Product Surveillance Registry REVERSE Post Approval Study
The purpose of the REVERSE Post Approval Study (PAS) is to confirm the benefit observed in the REVERSE and RAFT pivotal studies in "real-world" clinical practice.
- Trial name
- PSR-REVERSE (NCT01660035)
- Where
- 123 sites in United States, Belgium and 8 more
- Volunteers
- 155 people
- Sponsor
- Medtronic
Severe Isolated Left Ventricular Dysfunction, Severe Biventricular Dysfunction
Berlin Heart EXCOR Pediatric Post Approval Study
The purpose of this post-approval study of the EXCOR® Pediatric VAD is to evaluate whether safety and outcomes of the device use in the commercial setting are comparable to the safety and outcomes of the device use in the IDE…
- Trial name
- NCT01674699
- Testing
- EXCOR Pediatric
- Volunteers
- 49 people
- Sponsor
- Berlin Heart, Inc
Left Ventricular Dysfunction, Coronary Artery Disease
Impella®-Supported PCI in High-Risk Patients With Complex Coronary Artery Disease and Reduced Left Ventricular Function
The purpose of this study is to assess if using the Impella® CP (or Impella® 2.5) device during high-risk PCI in patients with reduced left-sided heart function will result in an improvement in symptoms, heart function and health…
- Trial name
- PROTECT IV (NCT04763200)
- Testing
- Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®, IABP Intra-aortic balloon pump
- Where
- 110 sites in United States, Canada and 5 more
- Volunteers
- 1,252 people
- Sponsor
- Abiomed Inc.
Tricuspid Insufficiency, Tricuspid Regurgitation (TR)
PASCAL Precision-GDMT Registry
The goal of this observational study is to demonstrate that successful tricuspid valve repair with the PASCAL Precision System in participants with at least severe tricuspid insufficiency and left ventricular dysfunction will be…
- Conditions
- Tricuspid Insufficiency, Tricuspid Regurgitation (TR), Left Ventricular Cardiac Dysfunction, Left Ventricular (LV) Systolic Dysfunction
- Trial name
- PASCAL (NCT07578129)
- Volunteers
- 50 people
- Sponsor
- Ceric Sàrl
Aortic Regurgitation, Aortic Valve Insufficiency
The JenaValve ALIGN-AR LVAD Registry
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically…
- Conditions
- Aortic Regurgitation, Aortic Valve Insufficiency, Aortic Insufficiency, Aortic Valve Disease
- Trial name
- JENA-VAD (NCT06594705)
- Testing
- JenaValve Trilogy Heart Valve System
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- JenaValve Technology, Inc.