Clinical trials: Cardiac Dysfunction
Heart Failure, Atrial Fibrillation
Mascot Study: Management of Atrial Fibrillation (AF) Suppression in AF-Heart Failure (HF) COmorbidity Therapy
The purpose of this study is to evaluate whether adding AF Suppression™ to cardiac resynchronization therapy (CRT) improves the prognosis of heart failure patients benefiting from cardiac resynchronization therapy.
- Conditions
- Heart Failure, Atrial Fibrillation, Ventricular Dysfunction
- Trial name
- MASCOT (NCT00187252)
- Testing
- Atrial Overdrive Pacing
- Where
- Italy
- Volunteers
- 380 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Congestive
Evaluation of the Safety and Effectiveness of the OPTIMIZER System in Subjects With Heart Failure: FIX-HF-5
The purpose of this study is to determine whether treatment with the OPTIMIZER System is safe and effective in patients with moderate to severe heart failure symptoms.
- Trial name
- NCT00112125
- Testing
- OPTIMIZER System
- Where
- United States
- Volunteers
- 428 people
- Sponsor
- Impulse Dynamics
Left Ventricular Systolic Dysfunction, Heart Failure (Pediatric)
A Study to Learn More About How Well Finerenone Works, How Safe it is, and How it Moves Into, Through, and Out of the Body Compared to Placebo When Taken With Standard Treatment in Children With Heart Failure and Left Ventricular Systolic Dysfunction
Researchers are looking for a better way to treat children who have heart failure with left ventricular systolic dysfunction (LVSD).
- Trial name
- FIORE (NCT07188805)
- Testing
- Finerenone (Kerendia, BAY94-8862)
- Where
- 133 sites in United States, Argentina and 21 more
- Volunteers
- 111 people
- Sponsor
- Bayer
Heart Failure
Open-label Extension Study to Evaluate Long-term Safety of Sacubitril/Valsartan in Pediatric Patients With HF
The purpose of this study was to evaluate long-term safety and tolerability and to provide post-trial access to sacubitril/valsartan to eligible participants who successfully completed CLCZ696B2319 (PANORAMA-HF) core study Part 2…
- Trial name
- NCT03785405
- Testing
- sacubitril/valsartan
- Where
- 79 sites in United States, Argentina and 25 more
- Volunteers
- 216 people
- Sponsor
- Novartis Pharmaceuticals
Heart Failure
Rheos System for the Treatment of HFpEF Heart Failure
The purpose of this clinical investigation (NCT00957073) is to continue long-term follow-up of device arm subjects enrolled in the HOPE4HF Trial, utilizing the BAROSTIM NEO™ LEGACY device for Implantable Pulse Generator (IPG)…
- Trial name
- HOPE4HF (NCT00957073)
- Testing
- Rheos® system
- Where
- 22 sites in United States
- Volunteers
- 19 people
- Sponsor
- CVRx, Inc.
Heart Failure, Congestive, Myocardial Infarction
IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting
The purpose of this study is to characterize current management of patients with either heart failure or prior myocardial infarction and left ventricular dysfunction and to assess the effect of education, specific clinical…
- Conditions
- Heart Failure, Congestive, Myocardial Infarction, Ventricular Dysfunction, Left
- Trial name
- IMPROVE-HF (NCT00303979)
- Where
- 144 sites in United States
- Volunteers
- 34,810 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure, Ventricular Dysfunction
B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients
The purpose of this study is to demonstrate that biventricular pacing (BiV) and left univentricular (left ventricular [LV] only) pacing are safe and effective for cardiac resynchronization therapy in heart failure patients…
- Conditions
- Heart Failure, Ventricular Dysfunction, Heart Diseases
- Trial name
- NCT00187213
- Testing
- Cardiac Resynchronization Therapy
- Where
- France
- Sponsor
- Abbott Medical Devices
Pulmonary Valve Insufficiency, Complex Congenital Heart Defect
ALTERRA Post-Approval Study
This study will monitor device performance and outcomes in subjects undergoing implantation of the Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent in the post-approval setting
- Conditions
- Pulmonary Valve Insufficiency, Complex Congenital Heart Defect, Tetralogy of Fallot, Pulmonary Regurgitation
- Trial name
- NCT05378386
- Testing
- Edwards Alterra Adaptive Prestent with SAPIEN 3 Transcatheter Pulmonary Valve System
- Where
- 24 sites in United States, Israel
- Volunteers
- 150 people
- Sponsor
- Edwards Lifesciences
Pulmonary Embolism, Acute Pulmonary Embolism
FlowTriever Pulmonary Embolectomy Clinical Study
Evaluate the safety and effectiveness of the FlowTriever System for use in the removal of emboli from the pulmonary arteries in the treatment of acute pulmonary embolism.
- Conditions
- Pulmonary Embolism, Acute Pulmonary Embolism, Submassive Pulmonary Embolism, Massive Pulmonary Embolism
- Trial name
- FLARE (NCT02692586)
- Testing
- FlowTriever System
- Where
- 18 sites in United States
- Volunteers
- 106 people
- Sponsor
- Inari Medical
Dilated Cardiomyopathy (DCM), Ischemic Cardiomyopathy
Dilated cardiomYopathy iNtervention With Allogeneic MyocardIally-regenerative Cells (DYNAMIC)
To determine the safety profile of CAP-1002 administered by multi-vessel intracoronary infusion in subjects with DCM. The study will further explore safety and exploratory efficacy endpoints of CAP-1002.
- Conditions
- Dilated Cardiomyopathy (DCM), Ischemic Cardiomyopathy, Nonischemic Cardiomyopathy, Heart Failure
- Trial name
- DYNAMIC (NCT02293603)
- Testing
- Allogeneic Cardiosphere-Derived Cells (CDCs)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Capricor Inc.
Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction
COSMIC-HF - Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure
The primary objectives of this study are (i) to select an oral modified release (MR) formulation and dose of omecamtiv mecarbil for chronic twice daily (BID) dosing in adults with heart failure and left ventricular systolic…
- Conditions
- Modified Release Oral Formulation, Left Ventricular Systolic Dysfunction, Chronic Heart Failure, History of Chronic Heart Failure
- Trial name
- COSMIC-HF (NCT01786512)
- Testing
- Omecamtiv Mecarbil Matrix F1 Formulation, Omecamtiv Mecarbil Matrix F2 Formulation, Omecamtiv Mecarbil Swellable Core Technology F2
- Where
- 101 sites in United States, Australia and 11 more
- Volunteers
- 544 people
- Sponsor
- Cytokinetics
Liver Surgery, Liver Dysfunction
Octaplas Pediatric Plasma Replacement Trial
The purpose of this study is to investigate the safety, tolerability and efficacy of octaplas in pediatric patients who require replacement of multiple coagulation factors.
- Conditions
- Liver Surgery, Liver Dysfunction, Coagulopathy, Cardiac Surgery
- Trial name
- NCT02050841
- Testing
- octaplas
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Octapharma
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
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.