Clinical trials: Device Malfunction
Cardiomyopathy, Coronary Artery Disease
Efficacy and Safety of Implantable Cardioverter-Defibrillator (ICD) Implantation in the Elderly
The overall aim of this trial is to study the safety and efficacy of ICD implantation as a primary prevention strategy of sudden cardiac death in patients 70 years and older.
- Conditions
- Cardiomyopathy, Coronary Artery Disease, Congestive Heart Failure, Myocardial Infarction
- Trial name
- I-70 (NCT02121158)
- Testing
- Implantable Cardioverter Defibrillator, Optimal Medical Therapy
- Where
- 5 sites in United States
- Volunteers
- 167 people
- Sponsor
- VA Office of Research and Development
Heart Failure
Clinical Validation Study for CPM Device
This study is designed to be a clinical validation study to ready the CPM System for FDA 510(k) submission. This study will be conducted as a prospective non-randomized.
- Trial name
- NCT05445206
- Testing
- CardioPulmonary Management Device (CPM)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Analog Device, Inc.
Liver Failure, Liver Diseases, Alcoholic
BRIDGE Device for Post-operative Pain Control
Auricular neurostimulation is a potential novel and non-invasive method of pain control following liver transplantation in a growing patient population with the probability of significant impact on economics and morbidity.
- Conditions
- Liver Failure, Liver Diseases, Alcoholic, Liver Diseases, Pain, Postoperative
- Trial name
- BRIDGE (NCT03265249)
- Testing
- BRIDGE device
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Duke University
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
Respiratory Failure
Performance of Baccalaureate Nursing Students in Insertion of Laryngeal Mask: a Trial in Mannequins
The purpose of this study is to compare if there difference in acquisition of knowledge and skills in airway management to baccalaureate nursing students submitted to different learning strategies: exhibition-dialogued class and…
- Trial name
- LMANURSING (NCT01659268)
- Testing
- Simulation class, Exhibition-dialogued class
- Where
- Brazil
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Congestive Heart Failure
Interventricular Delay of Lumax HF-T for Heart Failure
The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax HF-T with simultaneous biventricular pacing…
- Trial name
- NCT00508391
- Testing
- Optimized interventricular delay biventricular pacing
- Where
- 19 sites in United States, Switzerland
- Volunteers
- 122 people
- Sponsor
- Biotronik, 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
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3™ CE Mark Clinical Investigation Plan
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical…
- Trial name
- HM3 CE Mark (NCT02170363)
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 10 sites in Australia, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Developing a Non-invasive Cardiac Functional Health Status Measurement Device
This is a single-center, non-randomized study.Enrolled patients will be placed on a tilt table and a stress test will be performed in a total of 4 different positions. Their blood pressure will be measured at each position.
- Trial name
- NCT01877343
- Testing
- CVInsight(TM)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Florida
Congestive Heart Failure, Cardiorenal Syndrome
Nesiritide and Renal Function After the Total Artificial Heart
The prevalence of renal dysfunction after implantation of the artificial heart is high. The infusion of exogenous B-type natriuretic peptide (BNP) after implantation of the total artificial heart (TAH) improves renal function in…
- Trial name
- NCT01836809
- Testing
- nesiritide
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Virginia Commonwealth University
Heart Failure
Self-Management App for Patients With Left-Ventricular Assist Devices
The purpose of this study is to evaluate the use of VAD Care App in an out-patient mechanical circulatory support program. The specific aim for this pilot study is to obtain preliminary efficacy data of the VAD Care App as a…
- Trial name
- NCT03049748
- Testing
- Mobile phone app (VAD Care App), Usual LVAD Care
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- University of Michigan
Heart Failure
Biventricular Versus Right Ventricular Pacing
The study is a randomized, single-blind crossover prospective study in which investigators will determine the clinical outcomes of cardiac resynchronization therapy (CRT) pacing modalities in patients with left ventricular assist…
- Trial name
- NCT06298669
- Testing
- Biventricular Pacing, Right Ventricular Pacing
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Indiana University
Heart Failure
Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD
Left ventricular assist devices (LVADs) are one treatment option for people with congestive heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells (MPCs) into the heart during LVAD…
- Trial name
- NCT00927784
- Testing
- Mesenchymal Precursor cells (RevascorTM), Cryoprotective media alone
- Where
- 17 sites in United States
- Volunteers
- 10 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Heart Failure With Reduced Ejection Fraction
HF Patients With LVADs Being Treated With SGLT2i
The main purpose of this study is to observe outcomes of sodium-glucose co-transporter 2 inhibitors (SGLT2i) in heart failure (HF) patients with left ventricular assist devices (LVAD).
- Trial name
- NCT05278962
- Testing
- SGLT2i, No SGLT2i
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Chicago
End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT)
Development & Testing of a Decision Aid for LVAD Placement
The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment.
- Conditions
- End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners)
- Trial name
- VADDA (NCT02248974)
- Testing
- LVAD Decision Aid
- Where
- 7 sites in United States
- Volunteers
- 98 people
- Sponsor
- Baylor College of Medicine
Heart Failure, ICD
Comparing Rate Response With CLS Versus Accelerometer ICD Settings in Heart Failure Patients With BIOTRONIK CRT-Ds
Dr. Jonathan Hsu and Dr. Eric Adler are conducting a research study to find out more about how implantable cardiac defibrillator (ICD) settings can be adjusted to improve patient cardiovascular health and quality of life.
- Conditions
- Heart Failure, ICD, Chronotropic Incompetence
- Trial name
- CLASS (NCT02693262)
- Testing
- CLS Mode on Biotronik CRT-D, Accelerometer Mode on Biotronik CRT-D
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Intradialytic Hypotension, End Stage Renal Disease
Application of Impedance Threshold Device Technologies to Treat and Prevent Hypotension During Dialysis
The purpose of this study is to evaluate the application of the impedance threshold device during hemodialysis in children to optimize fluid removal, reduce the incidence of complications (such as cramps,vomiting and…
- Conditions
- Intradialytic Hypotension, End Stage Renal Disease, Low Blood Pressure
- Trial name
- ITD (NCT00576524)
- Testing
- ITD
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Children's Hospital of Philadelphia
Heart Failure, LVAD
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
- Trial name
- LVAD-ON-OFF (NCT04219618)
- Testing
- Off-Pump, On-Pump
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Heart Failure
Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure
Approximately 6.5 million people have heart failure (HF) in the United States, and 960,000 new cases are reported each year. HF is one of the most common hospital diagnosis among older adults.
- Trial name
- iCardia4HF (NCT03642275)
- Testing
- iCardia4HF
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- University of Illinois Chicago
Atrial Fibrillation, Heart Failure
Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure
The purpose of this study is to characterize the feasibility and impact of a diagnostic tool that may help clinicians identify when patients are at higher risk of visiting the hospital for a heart failure event.
- Trial name
- IDENTIFY-HF (NCT01486316)
- Testing
- Reveal XT® Insertable Cardiac Monitor, Heart Failure Risk Status Diagnostic
- Where
- 11 sites in United States
- Volunteers
- 24 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure