Clinical trials: Heart-Assist Devices
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device
The purpose of the study is to determine whether use of the Berlin Heart EXCOR® Pediatric Ventricular Assist Device for bridge-to-transplant is associated with a reasonable assurance of safety and probable benefit such that the…
- Trial name
- NCT00583661
- Testing
- EXCOR Pediatric
- Where
- 17 sites in United States, Canada
- Volunteers
- 48 people
- Sponsor
- Berlin Heart, Inc
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
3D Assessment of RV Function in Patients Undergoing LVAD Implantation
This goal of this study is to analyze images of the right ventricle taken via 3D transesophageal echocardiography (TEE) during left ventricular assist device (LVAD) implantation.
- Trial name
- NCT05376254
- Where
- Canada
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Alberta
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
Heart Murmurs, Wheezing
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app.
- Trial name
- KCI-1 (NCT07044128)
- Testing
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Where
- Peru
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Lapsi Health Holding B.V.
Cardiogenic Shock
Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic
Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device
- Trial name
- JenaMACS (NCT04451798)
- Testing
- Impella CP microaxial pump
- Where
- Germany
- Volunteers
- 20 people
- Sponsor
- University of Leipzig
Cardiovascular Diseases, Heart Diseases
Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs)
The Intermacs registry is a national quality improvement system designed to advance the understanding and application of mechanical circulatory support in order to improve the duration and quality of life in patients with…
- Conditions
- Cardiovascular Diseases, Heart Diseases, Heart Failure, Congestive
- Trial name
- NCT00119834
- Testing
- Mechanical Circulatory Support Device (MCSD)
- Where
- United States
- Volunteers
- 23,472 people
- Sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
Right Heart Failure
Serial Multiparametric Evaluation of Right Ventricular Function After Left Ventricular Assist Device Implantation
The primary purpose of this study is to investigate the evolution of Right Ventricular (RV) function before and after left ventricular assist device (LVAD) implantation, using novel echocardiographic quantification of RV size and…
- Trial name
- EuroEchoVAD (NCT03552679)
- Testing
- Echocardiography
- Where
- 9 sites in Germany, Hungary and 5 more
- Volunteers
- 600 people
- Sponsor
- Erasmus Medical Center
Heart Failure, Cardiomyopathies
Assess Safety and Probable Benefit of the EXCOR® Pediatric Ventricular Assist Device Under a Continued Access Protocol
The main purpose of this protocol is to provide a mechanism for continued access for patients that would have been enrolled into the primary cohorts of the IDE study.
- Trial name
- CAP (NCT01242891)
- Testing
- EXCOR® Pediatric Ventricular Assist Device
- Sponsor
- Berlin Heart, Inc
Chronic Heart Disorder, Lung Disorder
Wheeled Mobility in Everyday Life
The project will examine how mobility performance in real life tasks and environments is impacted by the use of specific types of wheeled mobility devices (wheeled walker, manual wheelchair, power wheelchair/scooter).
- Conditions
- Chronic Heart Disorder, Lung Disorder, Arthritis
- Trial name
- RERC-4a (NCT00981344)
- Testing
- Wheeled Mobility in Everyday Life:Effects of Wheelchair Type on Mobility Performance of Elders in Public Environments
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Duke University
End-stage Heart Failure
Long-Term Survival After LVAD Implantation in End-Stage Heart Failure
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
- Trial name
- NCT07382284
- Testing
- Left Ventricular Assist Device (LVAD) implantation
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Heart Failure Patients Before and After ICD Implantation
Heart-focused Anxiety in Patients With Heart Failure and ICD
The aim of the present study is to measure heart-focused anxiety, general anxiety, depression, PTSD and quality of life as well as type D personality in patients with heart failure before and after the implantation of a…
- Trial name
- Anxiety-CHF (NCT02226770)
- Testing
- Implantable Cardioverter Defibrillator (ICD)
- Where
- Germany
- Volunteers
- 132 people
- Sponsor
- University Hospital, Saarland
Left Ventricular Assist Device, Percutaneous Lead Management
Thoratec's Reduce Driveline Trauma Through Stabilization and Exit Site Management Study
The purpose of this study is to evaluate the feasibility of a Percutaneous Lead Management Kit for HeartMate II driveline stabilization and exit site management.
- Trial name
- RESIST (NCT01485666)
- Testing
- Percutaneous Lead Management Kit
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Heart Failure, Medication Compliance
Monitoring Medication Adherence in Left Ventricular Assist Device Recipients
The investigators aim to develop a novel and wireless method for monitoring medication adherence among heart failure patients with left ventricular assist devices (LVADs).
- Trial name
- NCT02388386
- Testing
- PROTEUS-SENSOR
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Scripps Translational Science Institute
Heart-Assist Devices, Infections
Complications in Pediatric Mechanical Circulatory Assistance: Evaluation of Infection Management.
Heart failure is a major cause of mortality and morbidity in children. Heart transplantation can significantly improve the prognosis of patients with severe heart failure, but access is limited by a shortage of transplants.
- Conditions
- Heart-Assist Devices, Infections, Heart Transplant Infection
- Trial name
- VADINFECT (NCT06464016)
- Testing
- Ventricular Assist Device with Berlin Heart EXCOR
- Where
- France
- Volunteers
- 47 people
- Sponsor
- Claude Bernard University
Congestive Heart Failure
Assessing Changes in Myocardial Tissue and Blood in Patients With Advanced Heart Disease
Hypothesis: Tissue and serum samples collected from end-stage heart failure patients receiving left ventricular assist device implantation (LVAD) or heart transplantation will provide information regarding the basic science of…
- Trial name
- NCT01099982
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Utah
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
ECMO and Acute MI
Use of ECMO in Acute MI
ECMO offers an acceptable cardiopulmonary support in adults with similar hospital survival rates as other mechanical support. It is versatile and salvages some patients, who may otherwise die.
- Trial name
- NCT00425685
- Volunteers
- 60 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
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, 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