Clinical trials: Cardiac Dysfunction
- Condition Cardiac Dysfunction
- Funder type Industry (pharma, biotech, devices)
- Age group Children (under 18)
Sudden Cardiac Death, Left Ventricular Dysfunction
LifeVest Safety and Efficacy in Real Life Settings in France
This post-market study is a prospective observational study evaluating the efficacy and safety of the LifeVest in real-life settings.
- Conditions
- Sudden Cardiac Death, Left Ventricular Dysfunction, Cardiac Event, Cardiac Arrythmias
- Trial name
- WEARIT-FR (NCT03319160)
- Testing
- Wearable Cardioverter Defibrillator
- Where
- 2 sites in France
- Volunteers
- 1,164 people
- Sponsor
- Zoll Medical Corporation
RV - Right Ventricular Abnormality, LV Dysfunction
Pediatric Ventricle Function Assessment Study
This study aims to develop a deep learning-based framework for right ventricular (RV) segmentation, prediction of RV fractional area change (FAC), and identification of pediatric RV dysfunction.
- Conditions
- RV - Right Ventricular Abnormality, LV Dysfunction, Pulmonary Hypertension, TOF
- Trial name
- NCT06739057
- Where
- United States
- Volunteers
- 3,993 people, healthy volunteers welcome
- Sponsor
- HBI Solutions Inc.
Duchenne Muscular Dystrophy
Safety and Efficacy of P-188 NF in DMD Patients
This is an open-label study to evaluate the safety, tolerability and efficacy of daily, subcutaneous dosing with P-188 NF (Carmeseal-MD™) in non-ambulatory boys with Duchenne Muscular Dystrophy (DMD).
- Trial name
- NCT03558958
- Testing
- P-188 NF
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Phrixus Pharmaceuticals, Inc.
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit
COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction
This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT)…
- Conditions
- Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
- Trial name
- NCT02744677
- Testing
- SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, SAPIEN 3 THV, SAPIEN 3 Ultra RESILIA THV
- Where
- 27 sites in United States
- Volunteers
- 108 people
- Sponsor
- Edwards Lifesciences
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
Duchenne Muscular Dystrophy (DMD)
Efficacy and Tolerability of Idebenone in Boys With Cardiac Dysfunction Associated With Duchenne Muscular Dystrophy
Idebenone is a synthetic analogue of coenzyme Q10 and is a powerful antioxidant and essential constituent of the process of energy production on the cellular level.
- Trial name
- DELPHI (NCT00654784)
- Testing
- idebenone
- Where
- Belgium
- Volunteers
- 21 people
- Sponsor
- Santhera Pharmaceuticals
Heart Failure, Cardiomyopathies
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases
- Trial name
- E-Motion (NCT04634708)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Berlin Heart GmbH
Asthma, Heart Failure
The General Breathing Record Study
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness.
- Conditions
- Asthma, Heart Failure, Pneumonia, Motor Neuron Disease
- Trial name
- GBRS (NCT03356288)
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- TidalSense
Transfusional Iron Overload, Transfusional Hemosiderosis
Evaluating Use of Deferasirox as Compared to Deferoxamine in Treating Cardiac Iron Overload
This is a clinical research study in patients who have iron overload in the heart due to chronic blood transfusions. The study will have 2 treatment groups and will compare the safety and efficacy of chelation therapy with a…
- Trial name
- CORDELIA (NCT00600938)
- Testing
- Core Study: Deferasirox, Core Study: Deferoxamine, Extension: deferoxamine to deferasirox
- Where
- 21 sites in Canada, China and 9 more
- Volunteers
- 197 people
- Sponsor
- Novartis Pharmaceuticals
Tricuspid Valve Disease, Tricuspid Valve Insufficiency
CorMatrix Cor TRICUSPID ECM Valve Replacement - Pivotal Study
The goal of this pivotal study is to demonstrate the safety and performance of the Cor TRICUSPID ECM (extracellular matrix) Valve (or Cor PEDIATRIC Tricuspid ECM Valve) for the surgical management of tricuspid valve disease and…
- Trial name
- NCT05742906
- Testing
- Tricuspid valve replacement with the Cor TRICUSPID ECM Valve
- Where
- 2 sites in United States
- Volunteers
- 92 people
- Sponsor
- Corvivo Cardiovascular, Inc.
Mitochondrial Diseases, Barth Syndrome
An Intermediate Size Expanded Access Protocol of Elamipretide
Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program.
- Trial name
- NCT04689360
- Testing
- elamipretide
- Sponsor
- Stealth BioTherapeutics Inc.
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Bridge to Cardiac Transplantation
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as a bridge to cardiac transplantation in end-stage heart failure patients who are listed…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121472
- Testing
- Thoratec HeartMate II Left Ventricular Assist System (LVAS)
- Where
- 36 sites in United States, Canada
- Volunteers
- 194 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Cardiovascular Disease
HeartMate 3 ELEVATE™ Registry
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
- Conditions
- Heart Failure, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- ELEVATE™ (NCT02497950)
- Testing
- HeartMate 3
- Where
- 26 sites in Austria, Czechia and 9 more
- Volunteers
- 540 people
- Sponsor
- Abbott Medical Devices
Pediatric Heart Failure
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week, Double-blind Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure
This study consists of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes, metabolizes and removes the drug LCZ696.
- Trial name
- NCT02678312
- Testing
- LCZ696, Enalapril
- Where
- 98 sites in United States, Argentina and 27 more
- Volunteers
- 393 people
- Sponsor
- Novartis Pharmaceuticals
Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis
COMPASSION XT PAS - Post-approval Study of the SAPIEN XT THV in Patients With Pulmonary Valve Dysfunction
This study will confirm the safety and effectiveness of the Edwards Lifesciences SAPIEN XT Transcatheter Heart Valve (THV) System in patients with a dysfunctional right ventricular outflow tract (RVOT) conduit with a clinical…
- Conditions
- Pulmonary Valve Insufficiency, Pulmonary Valve Stenosis, Heart Defects, Congenital, Congenital Abnormalities
- Trial name
- NCT02987387
- Testing
- SAPIEN XT THV
- Where
- 12 sites in United States
- Volunteers
- 57 people
- Sponsor
- Edwards Lifesciences
Tachyarrhythmias, Heart Failure
Safety and Clinical Performance of the Protecta ICD and CRT-D
The purpose of the study is two-fold. In Phase I (Protecta Clinical Study), system performance will be evaluated. In Phase II (PainFree SST), the inappropriate shock-free rate at one year of subjects implanted with a Medtronic…
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00982397
- Testing
- Protecta VR-ICD, Protecta DR-ICD or CRT-D
- Where
- 122 sites in United States, Austria and 19 more
- Volunteers
- 2,770 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiovascular Diseases, Microvascular Complications
Non-invasive Microvascular Assessment in Individuals at High Risk of Cardiovascular Disease From the SCAPIS2 Study
Microvascular dysfunction, particularly endothelial dysfunction, is increasingly recognized as a key mechanism underlying various cardiovascular diseases (CVD), including heart failure, ischemic heart disease, atherosclerosis…
- Trial name
- NCT07359768
- Where
- Sweden
- Volunteers
- 900 people
- Sponsor
- HJN Sverige AB/Neko Health
Heart Failure, Left Ventricular Systolic Dysfunction
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period.
- Trial name
- NCT05714085
- Testing
- Vericiguat tablet, Vericiguat suspension
- Where
- 109 sites in United States, Belgium and 28 more
- Volunteers
- 342 people
- Sponsor
- Merck Sharp & Dohme LLC
Ventricular Dysfunction, Ventricular Dysfunction, Left
Registry to Monitor Berlin Heart EXCOR® Pediatric VAD as a Bridge to Cardiac Transplantation.
The purpose of this post market surveillance is to continue monitoring the safety and effectiveness of the Berlin Heart EXCOR® Pediatric.
- Conditions
- Ventricular Dysfunction, Ventricular Dysfunction, Left, Ventricular Dysfunction, Right
- Trial name
- NCT03701997
- Testing
- EXCOR Pediatric
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Berlin Heart, Inc
Heart Failure, Univentricular Heart
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks…
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases
- Trial name
- RegiVe (NCT04782232)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Berlin Heart GmbH