Clinical trials: Device Malfunction
End-Stage Heart Failure, Cardiomyopathies
VentrAssistTM LVAD as a Bridge to Cardiac Transplantation - Feasibility Trial
The purpose of this trial is to determine the safety and feasibility of the VentrAssist LVAD in providing circulatory support for patients who require an LVAD as a bridge to cardiac transplantation.
- Trial name
- NCT00490347
- Testing
- VentrAssist Left Ventricular Assist Device
- Where
- 5 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ventracor
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Congestive Heart Failure
Assess Measurements of Wireless Cardiac Output Device
Heart failure is a common cardiovascular problem which is increasing in both prevalence and incidence and associated with substantial morbidity and mortality.
- Trial name
- Remote-CO-1 (NCT02252757)
- Testing
- CoVa
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Aventyn, 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
Tachyarrhythmias, Heart Failure
ConsultaTM CRT-D Clinical Evaluation Study
The purpose of the Consulta clinical study is to evaluate the overall system safety and clinical performance of the Consulta Implantable Cardioverter Defibrillator with Cardiac Resynchronization Therapy (CRT-D).
- Conditions
- Tachyarrhythmias, Heart Failure, Ventricular Dysfunction
- Trial name
- NCT00526162
- Testing
- Bi-ventricular Implantable Cardioverter Defibrillator
- Where
- Germany
- Volunteers
- 83 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Heart Failure, Cardiomyopathies
The Use of the EXCOR Active Driving Unit for Mobilization of Pediatric Patients With Ventricular Assist Device Support
The purpose of this observational study is to evaluate the performance of the Berlin Heart EXCOR Active driving unit while being used with the approved EXCOR ventricular assist device system.
- Conditions
- Heart Failure, Cardiomyopathies, Ventricular Dysfunction, Heart Diseases
- Trial name
- E-Motion (NCT04634708)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 24 people
- Sponsor
- Berlin Heart GmbH
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
Advanced Heart Failure
A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
- Trial name
- NCT07757451
- Testing
- DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
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
Acute Myocardial Infarction, Congestive Heart Failure
IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction
The primary objective is to evaluate the safety and effectiveness of the IK-5001 device for the prevention of ventricular remodeling and congestive heart failure when administered to subjects who had successful percutaneous…
- Conditions
- Acute Myocardial Infarction, Congestive Heart Failure, ST-Elevation Myocardial Infarction
- Trial name
- PRESERVATION-1 (NCT01226563)
- Testing
- IK-5001, Saline Solution
- Where
- 82 sites in United States, Australia and 7 more
- Volunteers
- 303 people
- Sponsor
- Bellerophon BCM LLC
Heart Failure
C-Pulse® System: A Heart Assist Device Clinical Study
Sunshine Heart is sponsoring a prospective, multi-center, randomized trial to assess the safety and efficacy of the C-Pulse® System ("C-Pulse").
- Trial name
- COUNTER-HF (NCT01740596)
- Testing
- C-Pulse® System Counterpulsation
- Where
- 28 sites in United States
- Volunteers
- 38 people
- Sponsor
- Nuwellis, Inc.
Acute Kidney Injury, Acute Kidney Injury Due to Sepsis
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry
QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.
- Trial name
- SAVE (NCT06517810)
- Testing
- QUELIMMUNE (SCD-PED)
- Where
- 15 sites in United States
- Volunteers
- 50 people
- Sponsor
- SeaStar Medical
Coronary Artery Disease, Heart Failure
Clinical Trial of Ventiflow LP Supporting High-risk Percutaneous Coronary Intervention(PCI)
The purpose of this prospective, multicenter, randomized controlled clinical trial is to evaluate the effectiveness of the transcatheter left ventricular assist system (Ventiflow LP) in providing circulatory support to patients…
- Conditions
- Coronary Artery Disease, Heart Failure, High-risk PCI
- Trial name
- NCT06754839
- Testing
- Percutaneous left ventricular assist device(Ventiflow LP), VA-ECMO
- Volunteers
- 250 people
- Sponsor
- Suzhou Hearthill Medical Technology Co.,LTD
Acute Renal Failure
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Although conventional hemodialysis removes waste products and corrects fluid imbalance, it does not replace critical absorptive, metabolic, endocrine, and immunologic functions performed by healthy renal tubule cells.
- Trial name
- NCT00511407
- Testing
- Renal tubule assist device
- Where
- 13 sites in United States
- Volunteers
- 58 people
- Sponsor
- RenaMed Biologics
Asthma, Heart Failure
The General Breathing Record Study
This study will test the use of a new handheld device (called the N-Tidal C), that measures a person's tidal breath carbon dioxide, in diagnosing the cause of someone's breathlessness.
- Conditions
- Asthma, Heart Failure, Pneumonia, Motor Neuron Disease
- Trial name
- GBRS (NCT03356288)
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- TidalSense
Elective Cardiac Surgery
Pleiades Safety and Feasibility Study
The "Pleiades" study is a non randomised, prospective, single center clinical trial that aims to evaluate the safety and the procedural feasibility of an innovative flow assist device (Pleioflow-RF) in adult patients undergoing…
- Trial name
- NCT05662501
- Testing
- Pleioflow-RF
- Where
- Greece
- Volunteers
- 40 people
- Sponsor
- Pleioflow
Heart Failure
Remote Monitoring of Ambulatory Intravenous Diuretics in Heart Failure
This study will aim to collect proof of concept data to inform the study design of a larger paired comparison study to establish key research questions about the Heartfelt device.
- Trial name
- MONITORED-HF (NCT05193084)
- Testing
- Heartfelt Device, Connected weighing scales
- Where
- United Kingdom
- Volunteers
- 23 people
- Sponsor
- Heartfelt Technologies
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, Cardio-Renal Syndrome
A Clinical Study of the Safety and Efficacy of a Wearable Device (CLS UF) That Delivers Continuous Administration of Glucose to Recirculated Peritoneal Dialysis Fluid for the Purpose of Ultrafiltration in Patients With Congestive Heart Failure
A single-center, prospective, non-randomized, clinical and first-in-human study. Each patient will be studied during a single treatment session of ten hours.
- Trial name
- NCT02772146
- Testing
- CLS UF
- Where
- Germany
- Volunteers
- 2 people
- Sponsor
- Triomed AB