Clinical trials: Device Malfunction, open to volunteers
- Condition Device Malfunction
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Heart Failure, Arrhythmia
BIO|CONCEPT.BIOMONITOR-HF Collect Clinical Data From Heart Failure Patients Using BIOMONITOR Devices With a Study Specific Research Software
[Plain language]: Heart failure (HF) patients often experience irregular heartbeats, known as arrhythmias. Atrial fibrillation (AF) is common among HF patients and can worsen their condition, leading to strokes and higher death…
- Conditions
- Heart Failure, Arrhythmia, Decompensated Heart Failure, Atrial Fibrillation
- Trial name
- NCT06989580
- Testing
- BIOMONITOR IV with study software
- Where
- 2 sites in Belgium, Germany
- Volunteers
- 300 people
- Sponsor
- Biotronik SE & Co. KG
Sepsis, Respiratory Failure
Safety, Tolerability and Performance of the NucleoCapture Device in the Reduction of Circulating CfDNA/NETs in Subjects with Sepsis
This is a prospective, multinational, multicentre, randomised, parallel-group, open-label study to assess the safety, tolerability and performance of the NucleoCapture extracorporeal apheresis device in the reduction of…
- Trial name
- NUC-CAP (NCT05647096)
- Testing
- NucleoCapture device
- Where
- 9 sites in Germany, Switzerland and 1 more
- Volunteers
- 73 people
- Sponsor
- Santersus AG
Heart Failure
KV-PREDICT Diagnostic Device in Patients With Heart Failure
This is a pilot, single-center, non-invasive interventional study evaluating the performance of KV-PREDICT, an investigational diagnostic medical device (Class IIa, not CE-marked), in adult patients with heart failure.
- Trial name
- PREDICT_HF (NCT07805213)
- Testing
- KV-PREDICT
- Where
- Italy
- Volunteers
- 120 people
- Sponsor
- KardioVis S.r.l.
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
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.
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.
Advanced Heart Failure
First in Human Study of the Icoms Flowmaker
The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump…
- Trial name
- FAIR (NCT07632586)
- Testing
- Cardiac assist device implantation during surgical intervention
- Where
- 2 sites in Czechia, France
- Volunteers
- 10 people
- Sponsor
- FineHeart
Decompensated Chronic Heart Failure
Observational Study Designed to Detect Decompensation of Congestive Heart Failure (dCHF) Using a Non-Invasive Wearable Device
This is a prospective, observational pilot study designed to develop a mathematical algorithm capable of predicting decompensation of congestive heart failure (dCHF) using physiologic data collected from a non-invasive wearable…
- Trial name
- NCT07350759
- Testing
- wearable ring device with multiple embedded sensors to detect heart rate, SVO2, respiratory rate, heart rate variability and a number of other related physiologic parameters
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- CHFDX,Inc.
Heart Failure
The AFteR Registry - Follow-up Study to Monitor the Efficacy and Safety of the Occlutech AFR in Heart Failure Patients
This study aims to monitor the safety and efficacy of Occlutech AFR device in patients with Heart Failure.
- Trial name
- AFR Registry (NCT04405583)
- Testing
- Occlutech Atrial Flow Regulator
- Where
- 36 sites in France, Germany and 6 more
- Volunteers
- 150 people
- Sponsor
- Occlutech International AB
Cardiac Pacing, Cardiac Pacemaker
BIO|STREAM.CSP Study
The registry is designed to assess outcome, performance and residual safety aspects of BIOTRONIK products which are used in the context of CSP based on long-term data from an unselected, real-life clinical set-up.
- Conditions
- Cardiac Pacing, Cardiac Pacemaker, Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy Devices
- Trial name
- NCT07393009
- Testing
- Implantation of the Solia CSP S pacing lead for LBBAP
- Where
- 46 sites in Australia, Austria and 11 more
- Volunteers
- 1,000 people
- Sponsor
- Biotronik SE & Co. KG
Heart Failure, Univentricular Heart
Registry to Assess the Safety and Feasibility of the Subpulmonary Support with the Novel Venous Cannula in Patients with Failing/Absence of the Right Heart
The purpose of the study is to monitor the clinical safety and performance of the EXCOR Venous Cannula in context of an EXCOR VAD therapy to ensure continued acceptability of identified risks, to enable detecting emerging risks…
- Conditions
- Heart Failure, Univentricular Heart, Ventricular Dysfunction, Heart Diseases
- Trial name
- RegiVe (NCT04782232)
- Testing
- No intervention
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- Berlin Heart GmbH
Heart Failure, Dyspnea
Evaluation of the Effectiveness of the Cardiostory Device in Distinguishing Heart Failure From Other Causes in Patients Presenting With Dyspnea.
This is a prospective, observational study conducted in the emergency department. Adult patients presenting with dyspnea will be enrolled, and study data will be collected from routine clinical assessments, including medical…
- Trial name
- CARDIOSTORY TN (NCT07685106)
- Testing
- Non invasive cardiac assessment with the CardioStory device
- Where
- 2 sites in Tunisia
- Volunteers
- 850 people
- Sponsor
- CardioStory INC
Aortic Valve Disease, Cardiovascular Diseases
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic Valve
The goal of this clinical trial is to evaluate the safety, effectiveness, and performance of Venus-Neo Surgical Aortic Valve in subjects who are clinically indicated for aortic valve replacement.
- Trial name
- METASAR (NCT05941455)
- Testing
- Venus-Neo Surgical Aortic Valve
- Where
- Germany
- Volunteers
- 155 people
- Sponsor
- Jilin Venus Haoyue Medtech Limited
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
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
Acute Kidney Injury
Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI)…
- Trial name
- NEUTRALIZE-AKI (NCT05758077)
- Testing
- Selective Cytopheretic Device, Standard of Care
- Where
- 36 sites in United States
- Volunteers
- 339 people
- Sponsor
- SeaStar Medical
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
Cardiac Rhythm Disorder, Heart Failure
Post-market Surveillance of Micorport CRM Cardiac Implantable Electronic Devices
The primary objective of the study is to assess the chronic safety of MicroPort CRM market-released systems.
- Conditions
- Cardiac Rhythm Disorder, Heart Failure, Sudden Cardiac Death
- Trial name
- PIANO (NCT05694572)
- Testing
- Implantation of a CIED
- Where
- Portugal
- Volunteers
- 2,500 people
- Sponsor
- MicroPort CRM
Heart Disease, Coronary Arterial Disease (CAD)
Feasibility Study of the Supira System in Patients Undergoing HRPCI With Support Beyond the PCI Procedure
The objective of this study is to assess the safety and feasibility of the Supira System in heart failure patients with low LVEF, undergoing HRPCI with use of mechanical circulatory support who may benefit from cardiovascular…
- Conditions
- Heart Disease, Coronary Arterial Disease (CAD), Heart Failure
- Trial name
- NCT07407816
- Testing
- Supira System
- Where
- 2 sites in Georgia
- Volunteers
- 45 people
- Sponsor
- Supira Medical