Clinical trials: Device Malfunction
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
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.
Acute Kidney Injury
Efficacy Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Kidney Injury
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 kidney injury (AKI).
- Trial name
- NCT01400893
- Testing
- SCD
- Where
- 26 sites in United States
- Volunteers
- 134 people
- Sponsor
- SeaStar Medical
Refractory Heart Failure
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant…
- Trial name
- NCT01001793
- Testing
- Levacor Ventricular Assist Device
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- World Heart Corporation
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
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
End-Stage Renal Disease Requiring Haemodialysis, Hemodialysis Access Failure (Disorder)
BONE ANCHORED PORT for Hemodialysis Treatment
A Bone Anchored Port System (BAP) will be implanted in the mastoid bone behind the ear, connected with a double lumen central venous catheter inserted in the jugular vein, and will be used in conjunction with an adapter as a…
- Trial name
- BAP (NCT02069860)
- Testing
- Bone Anchored Port System (BAP)
- Where
- Switzerland
- Volunteers
- 6 people
- Sponsor
- Cendres+Métaux
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
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
NYHA Class III Heart Failure
Correlation of SOZO BIS Measures With CardioMEMS PA Pressure
This study aims to establish the degree to which change in the ratio of ECF to TBW measured using the SOZO BIS device correlates with change in end-expiratory end-diastolic PAP measured using the CardioMEMS HF System (St.
- Trial name
- NCT02939053
- Testing
- SOZO
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- ImpediMed Limited
Pulmonary Hypertension, Congestive Heart Failure(CHF)
Observational Study of Patients Undergoing Diagnostic Right Heart Catheterization
The objective of this observational pilot study is to collect HemoCept device data from subjects undergoing diagnostic right heart catheterization (RHC) procedures.
- Conditions
- Pulmonary Hypertension, Congestive Heart Failure(CHF), Valve Disease, Heart
- Trial name
- NCT07224906
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- HemoCept Inc.
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
Heart Disease, Cardiovascular Disease
Remote Device Interrogation In The Emergency Department
A prospective, post market, non-randomized study to evaluate the reduction in time to interrogation for patients with St. Jude Medical remote care compatible devices interrogated by the unpaired Merlin@home transmitter in the…
- Conditions
- Heart Disease, Cardiovascular Disease, Heart Failure, Arrhythmias, Cardiac
- Trial name
- REMEDY (NCT01871090)
- Testing
- Unpaired remote monitoring transmitter
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- Abbott Medical Devices
Heart Failure
BOOST - Benefit of Frequent Optimization After Cardiac Resynchronization Therapy Device Replacement
Cardiac resynchronization therapy (CRT) has shown improvement in mortality and morbidity in patients with left ventricular systolic dysfunction and congestive heart failure.
- Trial name
- NCT00929474
- Testing
- QuickOpt - SJM CRT (Group 1), Control - SJM CRT (Group 2)
- Where
- 2 sites in United States
- Volunteers
- 17 people
- Sponsor
- Abbott Medical Devices
Functional Mitral Regurgitation, Heart Failure
Mitral Loop Cerclage(MLC) for Reducing Functional Mitral Regurgitation
To evaluate safety and feasibility of Mitral Loop Cerclage(MLC) Annuloplasty with CSTV for repair of functional mitral regurgitation.
- Trial name
- NCT02471664
- Testing
- Mitral Loop Cerclage Annuloplasty
- Where
- 2 sites in United States, South Korea
- Volunteers
- 5 people
- Sponsor
- Tau-MEDICAL Co., Ltd.
Acute on Chronic Liver Failure
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable patients with Acute on Chronic Liver Failure…
- Trial name
- DIALIVE _ACLF (NCT03065699)
- Testing
- DIALIVE Liver Dialysis Device
- Where
- 12 sites in Austria, Belgium and 6 more
- Volunteers
- 30 people
- Sponsor
- Yaqrit Ltd
Chronic Respiratory Failure, Acute Respiratory Failure
Validation Study of the EMILY AI Device in Acute and Chronic Respiratory Failure
Currently, there is no holistic solution for patients with respiratory diseases that includes oxygenation and management of a patient with respiratory disease, combining dynamic and automatic O2 administration and the detection…
- Trial name
- NCT06952816
- Testing
- Emily.AI
- Where
- 2 sites in Spain
- Volunteers
- 20 people
- Sponsor
- Aether Tech S.L.
Heart Failure, Transplant; Failure, Heart
EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
The purpose of this study is to evaluate the device performance and monitor the safety and effectiveness of the Berlin Heart EXCOR Active Driving System while being used with the approved EXCOR Pediatric Ventricular Assist…
- Conditions
- Heart Failure, Transplant; Failure, Heart, Congenital Heart Disease
- Trial name
- NCT05610787
- Testing
- EXCOR Active Driving System for Pediatric VAD
- Where
- 17 sites in United States
- Volunteers
- 40 people
- Sponsor
- Berlin Heart, Inc
Heart Failure, Diastolic, Edema Brain
Feasibility Study of a New Peripheral Oedema Monitor for Heart Failure
The study aims at assessing the usefulness of the Heartfelt1 device in patients suffering from heart failure, who have peripheral oedema. The device is non-contact and does not requires patient compliance to work.
- Conditions
- Heart Failure, Diastolic, Edema Brain, Decompensated Heartfailure
- Trial name
- NCT02993601
- Testing
- Heartfelt-1, Weighing scales, Medical grading of oedema
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Heartfelt Technologies
Coagulation
Left Ventricular Assist Device (LVAD) Specialized Centers of Clinically Orientated Research (SCCOR) Coagulation - Acute Intrinsic Pathway Antagonist (IPA)
The purpose of this study is to determine if post-operative administration of intrinsic pathway antagonist (TTP889) in patients on Left Ventricular Assist Device (LVAD) support will result in a 50% reduction of thrombin…
- Trial name
- NCT00909298
- Testing
- TTP889
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- vTv Therapeutics