Clinical trials: Device Malfunction, open to volunteers
Heart Failure With Reduced Ejection Fraction, Mitral Regurgitation
The CardioClip Study
The CardioClip study is exploring the use of a wireless sensor to monitor pressure in the pulmonary artery. This sensor is inserted much like the mTEER procedure, a non-surgical method through a vein in the groin.
- Trial name
- CardioClip (NCT06241430)
- Testing
- CardioMEMS
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Columbia University
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
Heart Failure, Telemonitoring
EXPLORATORY STUDY OF THE MYHEARTSENTINEL SYSTEM, A CARDIAMETRICS MEDICAL DEVICE
Background: Chronic heart failure represents a major public health challenge, affecting approximately 64 million people worldwide and generating high costs in terms of mortality, frequent hospitalizations, and medical expenses.
- Conditions
- Heart Failure, Telemonitoring, Right Heart Catheterisation
- Trial name
- ASEMC-DR (NCT07345533)
- Testing
- MYHEARTSENTINEL SYSTEM cutaneous DEVICE
- Where
- France
- Volunteers
- 70 people
- Sponsor
- University Hospital, Caen
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
Acute-On-Chronic Liver Failure, Anticoagulant Adverse Reaction
COOLEY- Study: aCute On chrOnic Liver failurE Using the cYtosorb Device
A Prospective, Single-Center trial, in Patients With Acute on Chronic Liver Failure. Study of Standard Medical Care Plus CytoSorb® Compared to Standard Medical Care Alone in a historical group.
- Conditions
- Acute-On-Chronic Liver Failure, Anticoagulant Adverse Reaction, Sarcopenia, Ultrasonography
- Trial name
- COOLEY (NCT06079021)
- Testing
- CytoSorb
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- University Hospital, Antwerp
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
Heart Failure, Cardiac Implantable Electrical Devices
Seasonal Physical Activity in Patients With Heart Failure With Cardiac Implantable Electronic Devices
The aim of this observational study is to determine the effect of seasonal changes on physical activity levels in heart failure patients with cardiac implantable electronic devices.
- Conditions
- Heart Failure, Cardiac Implantable Electrical Devices, Physical Activities
- Trial name
- CIED (NCT07420088)
- Testing
- follow-up study
- Where
- Turkey (Türkiye)
- Volunteers
- 24 people
- Sponsor
- Erol Olcok Corum Training and Research Hospital
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
Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease
Temporary MCS With the iVAC 2L Transaortic Device in High-risk PCI
Patients with coronary artery disease and undergoing high-risk percutaneous coronary intervention (PCI) are at increased risk of hemodynamic instability and poor outcomes.
- Conditions
- Ischemic Cardiovascular Disease, Multivessel Coronary Artery Disease, Coronary Artery Disease, Cardiogenic Shock
- Trial name
- POTOK (NCT07149714)
- Testing
- iVAC 2L
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Peritoneal Dialysis, Cardiovascular Diseases
The Effect of Physical Activity Level Evaluated by Wrist-wearable Devices on Cardiovascular Disease Risk and Other Outcomes in Peritoneal Dialysis Patients
This study aims to explore how daily physical activity (PA) levels affect the heart health and cognitive function of patients on peritoneal dialysis (PD).
- Conditions
- Peritoneal Dialysis, Cardiovascular Diseases, Myocardial Infarct, Heart Failure
- Trial name
- NCT06697418
- Where
- China
- Volunteers
- 266 people
- Sponsor
- Ruijin Hospital
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 Failure, Arrhythmias, Cardiac
Cardiology Research Dubrava Prospective Registry
Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2…
- Conditions
- Heart Failure, Arrhythmias, Cardiac, Atrial Fibrillation, Acute Coronary Syndrome
- Trial name
- CaRDr (NCT06090591)
- Testing
- SGLT-2 inh therapy, CIED implantation, thromboaspiration,
- Where
- Croatia
- Volunteers
- 3,000 people
- Sponsor
- University Hospital Dubrava
Cardiac Rehabilitation, Heart Failure
Cardiac REhabilitation COhort at the Medicine Campus DaVos to invEstigate Recovery
The RECOVER study, titled Cardiac Rehabilitation Cohort at the Medicine Campus Davos for Exploration of Recovery, is a prospective, non-interventional, monocentric cohort study conducted at the Hochgebirgsklinik Davos.
- Conditions
- Cardiac Rehabilitation, Heart Failure, Cardiac Arrest (CA), ACS (Acute Coronary Syndrome)
- Trial name
- RECOVER (NCT07096973)
- Where
- Switzerland
- Volunteers
- 10,000 people
- Sponsor
- Hochgebirgsklinik Davos
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
Wearable Device, Cardiovascular Disease
HEARTS in Sync + CardioWatch 287-2
The goal of this interventional study is to evaluate the implementation, usability, and clinical outcomes of a wearable medical-grade device in a virtual Cardiac Rehabilitation (CR) program, titled HEARTS in Sync.
- Conditions
- Wearable Device, Cardiovascular Disease, ASCVD Management, CHF - Congestive Heart Failure
- Trial name
- NCT07322510
- Testing
- Remote Patient Monitoring with Corsano CardioWatch 287-2
- Where
- Canada
- Volunteers
- 216 people
- Sponsor
- Nova Scotia Health Authority
Respiratory Failure with Hypoxia
Comparison Between Four Weaning Methods from High-velocity Nasal Insufflation Device in Acute Hypoxemic Respiratory Failure
High-flow nasal oxygen therapy (HFNO) is an innovative high-flow system that allows for delivering up to 60 liters/ min of heated and fully humidified gas with a fraction of inspired oxygen (FIO2) ranging between 21% and 100% .
- Trial name
- HVNI (NCT06746636)
- Testing
- High velocity nasal insufflation
- Volunteers
- 120 people
- Sponsor
- Assiut University
HFrEF - Heart Failure With Reduced Ejection Fraction
Impact of Barostimulation on Hemodynamics in Adults With Heart Failure
This study evaluates the effects of the implantation and adjustment of the CVRx Barostim device in adult patients with heart failure with reduced ejection fraction who are receiving maximally tolerated doses of guideline directed…
- Trial name
- BREATHE-HF (NCT07335510)
- Testing
- Baroreflex Activation Therapy
- Where
- 7 sites in United States
- Volunteers
- 58 people
- Sponsor
- Columbia University