Clinical trials: Device Malfunction
Acute Renal Failure
Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure
The purpose of this protocol is to evaluate the safety of a selective cytopheretic device (SCD) in patients that are on continuous renal replacement therapy (CRRT) for acute renal failure (ARF).
- Trial name
- NCT01072682
- Testing
- Selective cytopheretic device (SCD)
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- SeaStar Medical
Heart Failure
Right Ventricular Function and Exercise Capacity in Patients With Continuous-flow Left Ventricular Assist Devices
Exercise capacity in continous-flow left ventricular assist device (CF-LVAD) patients remains severely reduced post-implant. While the effect of right ventricular (RV) failure early after pump implantation, and its effect on…
- Trial name
- NCT02658136
- Testing
- Cardiac Computed tomography
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Finn Gustafsson
Stenosis of Vascular Prosthetic Devices, Implants and Grafts
Post-Approval Study for the FLAIR Endovascular Stent Graft
The purpose of this study is to confirm the long-term safety and effectiveness of the FLAIR Endovascular Stent Graft for treatment of stenoses at the venous anastomosis of ePTFE or other synthetic arteriovenous (AV) access grafts.
- Trial name
- RENOVA (NCT00677235)
- Testing
- FLAIR Endovascular Stent Graft, PTA
- Where
- United States
- Volunteers
- 270 people
- Sponsor
- C. R. Bard
Heart Failure, Congestive, Ventricular Dysfunction
Thoratec HeartMate II Left Ventricular Assist System (LVAS) for Destination Therapy
The purpose of this study is to determine the safety and effectiveness of the Thoratec HeartMate II Left Ventricular Assist System (LVAS) as Destination Therapy in end-stage heart failure patients who do not qualify for cardiac…
- Conditions
- Heart Failure, Congestive, Ventricular Dysfunction, Cardiomyopathies
- Trial name
- NCT00121485
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 47 sites in United States, Canada
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Ventricular Dysfunction
The Use of CoSeal (Sealant Agent) in Patients During Left Ventricular Assist Device Surgery
The purpose of this study is to evaluate the use of a device called CoSeal™. CoSeal™ is an FDA approved synthetic (man-made) surgical sealant which is currently used to help stop leaks in blood vessels during surgery.
- Trial name
- NCT01605019
- Testing
- CoSeal, BioGlue® Surgical Adhesive
- Where
- 2 sites in United States
- Volunteers
- 4 people
- Sponsor
- The Methodist Hospital Research Institute
Heart Failure
Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either heart transplant or for left ventricular…
- Trial name
- NCT01717209
- Testing
- Nitric Oxide, Prostacyclin
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Stanford University
Heart Failure, Medication Compliance
Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs).
- Trial name
- NCT02388386
- Testing
- PROTEUS-SENSOR
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Scripps Translational Science Institute
Heart Failure
Investigation to Optimize Hemodynamic Management of Left Ventricular Assist Devices Using the CardioMEMS™
This observational post market study is intended to characterize hemodynamic-guided management of patients with an existing left ventricular assist device (LVAD) to protocol specified target ranges and its impact on functional…
- Trial name
- INTELLECT 2-HF (NCT03247829)
- Testing
- Hemodynamic management using CardioMEMS HF System
- Where
- 23 sites in United States
- Volunteers
- 101 people
- Sponsor
- Abbott Medical Devices
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
Acute Respiratory Failure Requiring Mechanical Ventilation
Eye-Control Trial: Wearable Eye-Tracking Device as Means of Communication
The purpose of this study is to evaluate the feasibility of use of a wearable communication device for critically ill patients who are admitted to the intensive care unit (ICU) and mechanically ventilated.
- Trial name
- NCT04582149
- Testing
- EyeControl Eye-tracking Device
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Emory University
Heart Failure
Stem Cell Therapy in Patients With Severe Heart Failure & Undergoing Left Ventricular Assist Device Placement
The purpose of this study is to determine if the delivery of cells just after implantation of left ventricular assist device will help to improve the pumping function of your heart and minimize heart enlargement in the future.
- Trial name
- ASSURANCE (NCT00869024)
- Testing
- Intramyocardial Delivery of Bone Marrow Derived Mononuclear Cells
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- University of Minnesota
Heart Failure, Dilated Cardiomyopathy
Harefield Recovery Protocol Study for Patients With Refractory Chronic Heart Failure
The purpose of this study is to evaluate whether patients with chronic heart failure not due to coronary artery disease who require use of a left ventricular assist device (LVAD) for refractory heart failure can recover…
- Trial name
- HARPS (NCT00585546)
- Testing
- clenbuterol
- Where
- 7 sites in United States
- Volunteers
- 18 people
- Sponsor
- Francis D. Pagani
Arrhythmias, Cardiac
Continuous Cardiac Arrhythmia Monitoring in Hemodialysis Patients
Hemodialysis patients have a rate of fatal arrhythmias that is 40 times greater than the general population, but the causes and types of fatal arrhythmias they experience is unclear.
- Trial name
- CARE-ESRD (NCT00932659)
- Testing
- continuous cardiac monitoring device (REVEAL, Medtronic)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Duke University
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Continued Access Protocol
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the…
- Trial name
- MOMENTUM 3 CAP (NCT02892955)
- Testing
- HeartMate 3 LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,685 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Effective Study of ARNI on Ventricular Arrhythmia in HFrEF Patients With ICD or CRT-D (RHYTHM)
The purpose of this study was to generate effectiveness data of Angiotensin receptor neprilysin inhibitor (ARNI), in the Chinese Heart failure with reduced ejection fraction (HFrEF) patients with implantable cardioverted…
- Trial name
- RHYTHM (NCT04491136)
- Testing
- ACEI/ARB, ARNI
- Where
- 23 sites in China
- Volunteers
- 201 people
- Sponsor
- Novartis Pharmaceuticals
Left Sided Heart Failure, Left Ventricular Assist Device
Ventricular Assist Device Anti-Factor Xa (VAD ANTIX) Monitoring Study: a Prospective Randomized Feasibility Trial
This study evaluates two different methods for monitoring a patient's anti-clotting [heparin] therapy after they receive a heart pump implant [left ventricular assist device -LVAD].
- Conditions
- Left Sided Heart Failure, Left Ventricular Assist Device, Anticoagulant Therapy, Gastro Intestinal Bleeding
- Trial name
- VAD-ANTIX (NCT03143569)
- Testing
- aPTT guided heparin management, Anti-factor Xa guided heparin management
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Washington University School of Medicine
Heart Failure
Building Strength Through Rehabilitation for Heart Failure Patients (BISTRO-STUDY)
In the U.S., 5.7 million people have heart failure (HF), 915,000 new cases are diagnosed each year, and both incidence and prevalence are increasing due to the aging of the population and to better survival from ischemic heart…
- Trial name
- NCT03615469
- Testing
- Transcutaneous electrical stimulation, Neuromuscular electrical stimulation
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Indiana University
HIV
Condom Performance in a Longitudinal Enhanced Assessment of User Experiences
This study will enroll 252 men who have sex with men (MSM) and 252 men who have sex with women (MSW) in a double-blind, three-way randomized crossover trial with conditions of fitted, thin, and standard condoms.
- Trial name
- C-PLEASURE (NCT02753842)
- Testing
- 5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms
- Volunteers
- 504 people, healthy volunteers welcome
- Sponsor
- Global Protection Corp.
Heart Failure
International Study to Determine if AdreView Heart Function Scan Can be Used to Identify Patients With Mild or Moderate Heart Failure (HF) That Benefit From Implanted Medical Device
This is an event-driven Phase IIIb, multicentre, randomised, clinical study to demonstrate the efficacy of AdreView™ imaging for appropriately guiding the decision of implantable cardioverter defibrillator (ICD) implantation, in…
- Trial name
- ADMIRE-ICD (NCT02656329)
- Testing
- Iobenguane I -123 Injection, Implantable Cardioverter Defibrillator, Thyroid blocking
- Where
- 94 sites in United States, Canada and 8 more
- Volunteers
- 395 people
- Sponsor
- GE Healthcare
Heart Failure，Congestive, Heart Failure New York Heart Association Class IV
Nicotinamide Riboside in LVAD Recipients
While preliminary data show that oral nicotinamide riboside (NR) supplementation increases myocardial levels of oxidized nicotine-adenine dinucleotide (NAD+) levels in mice, there has been no direct evidence that suggests oral NR…
- Conditions
- Heart Failure，Congestive, Heart Failure New York Heart Association Class IV, Mitochondrial Alteration
- Trial name
- PilotNR-LVAD (NCT03727646)
- Testing
- Nicotinamide riboside
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- University of Washington