Clinical trials: Helping Behavior
Cardiac Disease
Point-of-Care Echocardiography With Assistance Technology
Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA…
- Trial name
- NCT03897140
- Testing
- Diagnostic Test: Limited Echocardiogram
- Where
- 2 sites in United States
- Volunteers
- 240 people, healthy volunteers welcome
- Sponsor
- Sara Guttas
Severe to Morbid Obesity and Type 2 Diabetes
Study of Weight Loss Using Gastric Stimulation in Obese Patients With Type 2 Diabetes
The purpose of this study is to test the effect of an implanted device that stimulates the stomach on weight loss in patients suffering from obesity and type 2 diabetes.
- Trial name
- ASSIST (NCT00200018)
- Testing
- Enterra Therapy System (H9900014)
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- MedtronicNeuro
Driveline Heart-assisted Device Related Infection
Driveline Silicone Skin Interface Registry
The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a…
- Trial name
- SSI (NCT01577433)
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Shock, Cardiogenic, High Risk Percutaneous Coronary Interventions
Synchronized Cardiac Assist for Cardiogenic Shock
The purpose of this study is to collect prospective safety and performance information for the i-COR® device using synchronized cardiac assist in the setting of combined heart-lung failure or in high risk percutaneous…
- Trial name
- NCT02697006
- Testing
- i-cor Synchronized Cardiac Assist Device
- Where
- Germany
- Volunteers
- 47 people
- Sponsor
- Xenios AG
Coronary Artery Disease
Phimume® Percutaneous Left Ventricular Assist System Study
The primary purpose of this clinical trial is to evaluate the safety and efficacy of the percutaneous left ventricular assist system versus extracorporeal membrane oxygenation (ECMO) for circulatory support during high-risk PCI.
- Trial name
- NCT06639321
- Testing
- Percutaneous Ventricular Assist System, extracorporeal membrane oxygenation (ECMO)
- Where
- 6 sites in China
- Volunteers
- 250 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
High-Risk PCI
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump…
- Trial name
- NCT07010965
- Testing
- NyokAssist™, IABP Intra-aortic balloon pump
- Where
- 12 sites in China
- Volunteers
- 236 people
- Sponsor
- magAssist, Inc.
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
Intraoperative Hypotension
Feasibility Study of E-Fusion Vasopressor Titration-Assist During Multi-Level Spine Surgery
This is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery.
- Trial name
- NCT07840937
- Testing
- E-Fusion Vasopressor Titration-Assist
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Autonomous Healthcare, Inc.
Heart Failure
The ARIES HeartMate 3 Pump IDE Study
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus…
- Trial name
- NCT04069156
- Testing
- LVAD Implant, Aspirin 100mg
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 628 people
- Sponsor
- Abbott Medical Devices
Right Heart Failure, Left Ventricular Assist Device
CRD-102 for Right Heart Failure in Patients With Left Ventricular Assist Devices
This is a Phase 1b/IIa, single centre, non-randomised open-label uncontrolled study to assess safety, effect and PK of oral CRD-102 in patients with RHF associated with the presence of an LVAD.
- Trial name
- NCT03217331
- Testing
- CRD-102
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Cardiora Pty. Ltd.
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Renal Impairment After Cardiac Surgery, Renal Impairment
Groundbreaking Renal Assist Device Intervening to ENhance cardioThoracic Surgery Outcomes
Patients with renal insufficiency who undergo cardiac surgery with cardiopulmonary bypass (CPB) are at significant risk for exacerbation of renal dysfunction postoperatively.
- Conditions
- Renal Impairment After Cardiac Surgery, Renal Impairment, Acute Kidney Injury
- Trial name
- GRADIENT (NCT07017933)
- Testing
- Renal assist device
- Where
- 7 sites in United States, Poland
- Volunteers
- 124 people
- Sponsor
- 3ive Labs
Heart Failure
Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device (LVAD) and Medical Management
The purpose of this study is to evaluate and compare the effectiveness of the HeartMate II (HM II) Left Ventricular Assist Device (LVAD) support versus OMM in ambulatory NYHA Class IIIB/IV heart failure patients who are not…
- Trial name
- ROADMAP (NCT01452802)
- Testing
- HM II (HeartMate II LVAD), OMM (Optimal Medical Management)
- Where
- 52 sites in United States
- Volunteers
- 200 people
- Sponsor
- Abbott Medical Devices
Type 1 Diabetes (T1D)
Evaluation of the Safety and Effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery System (NMX8) in Adults Living With Type 1 Diabetes
The purpose of the study is to evaluate the safety and the effectiveness of the Novel Medtronic Experimental Automated Insulin Delivery system, named MiniMed NMX8 system (referred also to as NMX8 system), in comparison with other…
- Trial name
- ELEVATE (NCT07401901)
- Testing
- NMX8 System - Treatment arm, AID Therapy, NMX8 System - Control Arm
- Where
- 21 sites in France, Germany and 4 more
- Volunteers
- 230 people
- Sponsor
- Medtronic MiniMed, Inc.
Ischemic Stroke
ASSIST Registry Studying Various Operator Techniques
The purpose of this Registry is to assess the procedural success and clinical outcomes associated with various operator techniques for mechanical thrombectomy in large vessel occlusions (LVO).
- Trial name
- NCT03845491
- Testing
- Mechanical Thrombectomy
- Where
- 72 sites in United States, Belgium and 9 more
- Volunteers
- 1,492 people
- Sponsor
- Stryker Neurovascular
Fulminant Hepatic Failure
Safety and Efficacy of the Extracorporeal Liver Assist Device (ELAD®) In Patients With Fulminant Hepatic Failure (FHF)
This is a multicenter, open-label, randomized, concurrent control study of subjects with FHF. Subjects meeting the eligibility requirements of the study will be randomly assigned in a 2:1 ratio to receive either standard medical…
- Trial name
- ELAD (NCT00832728)
- Testing
- Standard of Care, ELAD®
- Where
- 12 sites in United States
- Sponsor
- Vital Therapies, Inc.
Anticoagulation, Left Ventricular Assist Device
Study of Reduced Anti-coagulation/Anti-platelet Therapy in Patients With the HeartMate II Left Ventricular Assist System (LVAS) (TRACE)
The purpose of this observational study is to obtain multi-center data on HeartMate II (HMII) patients managed with reduced anticoagulation or anti-platelet regimes, and the incidence of thrombotic and bleeding adverse events…
- Trial name
- TRACE (NCT01477528)
- Where
- 18 sites in United States, Austria and 3 more
- Volunteers
- 201 people
- Sponsor
- Abbott Medical Devices
Human Immunodeficiency Virus Infection
Real-life Effectiveness of the Kaletra Adherence Support Assistance (KASA) Program
The overall purpose of the study was to describe the real-life adherence, effectiveness and safety of the Kaletra Adherence Support Assistance (KASA) Program in human immunodeficiency virus (HIV)-positive patients who were…
- Trial name
- NCT01662336
- Testing
- Lopinavir / ritonavir, Kaletra Adherence Support Assistance Program
- Volunteers
- 173 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
- Trial name
- CAP (NCT01242891)
- Testing
- EXCOR® Pediatric Ventricular Assist Device
- Sponsor
- Berlin Heart, Inc
Hepatitis C, Chronic, Hepacivirus
Adherence in Patients Receiving PegIntron and Rebetol for Hepatitis C in Conjunction With a Patient Assistance Program (Study P04206)
Patients receiving a patient assistance program during therapy for Hepatitis C will be enrolled into this study. All patients will receive PegIntron and Rebetol (according to the label) and the patient assistance program, which…
- Trial name
- NCT00723879
- Testing
- Peginterferon alfa-2b (SCH 54031), Ribavirin (SCH 18908), Patient assistance program
- Volunteers
- 115 people
- Sponsor
- Merck Sharp & Dohme LLC