Clinical trials: Device Malfunction
Advanced Heart Failure
DuoCor 2 DOMINATE Study
Advanced heart failure is a life-threatening condition characterized by the inability of one or both ventricles to maintain adequate blood circulation.
- Trial name
- NCT07233876
- Testing
- DuoCor Ventricular Assist System
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction
A Study Evaluating an Implantable Cardiac Microcurrent Device in Patients With Chronic Heart Failure
This study evaluates the safety and performance/effectiveness of the C-MIC System, an active implantable medical device designed to treat patients with heart failure with reduced ejection fraction (HFrEF).
- Conditions
- Chronic Heart Failure, Left Ventricular (LV) Systolic Dysfunction, Ischemic and Non-ischemic Cardiomyopathy
- Trial name
- NCT07795359
- Testing
- Subcutaneous cardiac microcurrent treatment
- Volunteers
- 60 people
- Sponsor
- Berlin Heals GmbH
Heart Failure
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal (PAPIRUS III)
The PAPIRUS III study will continue to follow patients initially enrolled in PAPIRUS II. Pressure readings from the investigational device will continue to be collected and will be correlated to physiological changes during…
- Trial name
- PAPIRUSIII (NCT00893828)
- Where
- Germany
- Volunteers
- 18 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
MDT-1118 Japan DT Study
To evaluate the safety and effectiveness of the MDT-1118 VAD in a patient population for destination therapy (long term support) of advanced heart failure.
- Trial name
- MDT-1118 Japan (NCT03884504)
- Testing
- Ventricular Assist Device System
- Where
- Japan
- Volunteers
- 10 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Lancashire Objective Volume Evaluation of Leg Oedema in Heart Failure
Patients with heart failure (HF) who recently received treatment with IV diuretics for worsening congestion or outpatients with HF and peripheral oedema treated with at least 80 mg furosemide (or equivalent)/day will be recruited…
- Trial name
- LOVE-HF (NCT04787380)
- Testing
- Heartfelt device
- Where
- United Kingdom
- Volunteers
- 27 people
- Sponsor
- Heartfelt Technologies
Mitral Valve Disease, Mitral Valve Stenosis
Early Feasibility Study for the Foldax TRIA Mitral Heart Valve Replacement
The purpose of this study is to conduct the initial clinical investigation of the Foldax Polymer Mitral Valve to collect evidence on the device's safety and performance.
- Conditions
- Mitral Valve Disease, Mitral Valve Stenosis, Mitral Valve Failure
- Trial name
- FOLDAX (NCT04717570)
- Testing
- Foldax TRIA Mitral Valve
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Foldax, Inc
Sinus Node Disease, AV Block
Ingenio Device Algorithm Study
The purpose of the IVORY Study is to gather data to support global submissions/approvals for some models of the Ingenio device family.
- Conditions
- Sinus Node Disease, AV Block, Heart Failure
- Trial name
- IVORY (NCT01441583)
- Testing
- RAAT, RYTHMIQ
- Where
- 21 sites in Austria, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Boston Scientific Corporation
Heart Failure
HARMONY Trial : To Evaluate a Therapeutic and Monitoring Device(NOVAtria System) for Heart Failure Management
The objective of the HARMONY trial is to evaluate the safety and efficacy of implantable left atrial pressure sensor and interatrial shunt system for the treatment of chronic heart failure with reduced left ventricular ejection…
- Trial name
- NCT07402239
- Testing
- NOVAtria System, Control
- Where
- 15 sites in China
- Volunteers
- 330 people
- Sponsor
- United Innomed(Shanghai) Limited
Cardiogenic Shock, Heart Failure
Magenta Elevate™ Clinical Feasibility Study in Cardiogenic Shock
The Elevate™ CS Clinical Feasibility Study is designed to evaluate the initial safety, effectiveness, and device performance of the Magenta Elevate™ System in patients with cardiogenic shock due to isolated or predominant left…
- Conditions
- Cardiogenic Shock, Heart Failure, Acute Myocardial Infarction (AMI)
- Trial name
- NCT07293923
- Testing
- Elevate™ System
- Where
- 8 sites in Georgia, Israel
- Volunteers
- 10 people
- Sponsor
- Magenta Medical Ltd.
Pancreatic Ductal Adenocarcinoma (mPDAC), Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
A Study Comparing Whole-Body Heat Treatment Plus Systemic Therapy to Systemic Therapy Alone, for Advanced Pancreatic Cancer
Pancreatic ductal adenocarcinoma (PDAC) is associated with poor prognosis and limited treatment options following failure of first-line therapy.
- Trial name
- MATTERS-2 (NCT07711067)
- Testing
- Whole-body hyperthermia, Standard-of-Care Systemic therapy
- Where
- 4 sites in Belgium, Spain
- Volunteers
- 95 people
- Sponsor
- ElmediX
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
Refractory Heart Failure, Cardiovascular Diseases (CVD)
European Study of the BrioVAD Heart Pump for Advanced Heart Failure
This clinical investigation evaluates the safety and clinical performance of the BrioVAD Left Ventricular Assist System in patients with advanced, refractory left ventricular heart failure who require mechanical circulatory…
- Trial name
- BRIOLIFE (NCT07252531)
- Testing
- LVAD implantation
- Where
- 2 sites in Netherlands
- Volunteers
- 60 people
- Sponsor
- BrioHealth BV
Atrial Fibrillation, Congestive Heart Failure
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and Pace
The purpose of this study is to demonstrate the safety and effectiveness of biventricular pacing over conventional right ventricular pacing in patients with persistent or permanent, symptomatic atrial fibrillation undergoing…
- Trial name
- AVAIL (NCT00356057)
- Testing
- Protos DR/CLS and Stratos LV CRT pacemakers
- Where
- 10 sites in United States
- Volunteers
- 153 people
- Sponsor
- Biotronik, Inc.
Heart Failure
Medtronic Observational Study in the "Real World" of Implantable Electronic Cardiac Devices
The Observational Study in the "Real World" of Implantable Electronic Cardiac Devices will enable the construction of an electronic database with local access to clinical information, which will collect and disseminate…
- Trial name
- OBSERVE (NCT01189630)
- Where
- Brazil
- Volunteers
- 3,500 people
- Sponsor
- Medtronic Comercial Ltda.
Heart Failure, Congestive, Sleep Apnea Syndromes
Evaluation of a Portable Device for Assessing Sleep Disordered Breathing in Congestive Heart Failure
The purpose of this study is to evaluate an approved, portable device for assessing Sleep Disordered Breathing in Congestive Heart Failure.
- Trial name
- NCT00493948
- Testing
- ApneaLink
- Where
- Australia
- Volunteers
- 35 people
- Sponsor
- ResMed
HFrEF - Heart Failure With Reduced Ejection Fraction
Vsling™ III: Clinical Evaluation of the Vsling™ Device for Ventricular Repair in Patients With Heart Failure
Prospective, multi-center, open-label clinical study of the feasibility and initial safety and performance of the Vsling™ in patients with heart failure (HF) with evidence of reduced left ventricular ejection fraction, associated…
- Trial name
- Vsling III (NCT06002386)
- Testing
- Vsling
- Where
- Poland
- Volunteers
- 10 people
- Sponsor
- Cardiac Success
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Congestive Heart Failure, Atrial Arrhythmia, Atrial Tachyarrhythmia, Atrial Fibrillation
Clinical Investigation of the Medtronic Concerto™ Device
Heart failure is a progressive disease that decreases the pumping action of the heart. This may cause a backup of fluid in the heart and may result in heart beat changes.
- Trial name
- NCT00268320
- Testing
- Cardiac Resynchronization Therapy+Implantable Cardioverter Defibrillator
- Where
- 51 sites in United States, Austria and 10 more
- Volunteers
- 270 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Kidney Injury
Safety and Efficacy of a Selective Cytopheretic Device (SCD) in Pediatric Patients With Acute Kidney Injury (AKI).
The SCD (Selective Cytopheretic Device) is an extracorporeal device used as an adjunct to renal replacement therapy (RRT) to improve the outcomes of pediatric patients with acute kidney injury (AKI).
- Trial name
- SCD-PED-01 (NCT02820350)
- Testing
- SCD-F40
- Where
- 4 sites in United States
- Volunteers
- 19 people
- Sponsor
- CytoPherx, Inc
Hydrocephalus
ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH)…
- Trial name
- SCNPH (NCT01323764)
- Testing
- ShuntCheck test
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- NeuroDx Development