Clinical trials: Mechanical Circulatory Support
Congenital Heart Disease, Advanced Heart Failure
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart…
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation
- Trial name
- TORCH-003 (NCT07837024)
- Testing
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
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.
Cardiogenic Shock
CorVad Myocardial Infarction Complicated with Cardiogenic Shock Trial
Cardiogenic shock a serious complication of a heart attack (myocardial infarction). Despite evaluation of several new treatments during the last decade, the mortality in patients with cardiogenic shock still exceeds 50%.
- Trial name
- Corvad AMICS (NCT06886113)
- Testing
- Conventional circulatory support, CorVad
- Where
- China
- Volunteers
- 269 people, healthy volunteers welcome
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Cardiogenic Shock, Short Term Mechanical Circulatory Support
Outcomes in CArdiogenic SHock Patients Treated by MEchanical Circulatory suppoRt devicE : Impact of Shock Team
In this before-after monocenter study, the authors teste the hypothesis that the implementation of a dedicated shock team could improve the outcome of patients with refractory cardiogenic shock assisted by mechanical circulatory…
- Conditions
- Cardiogenic Shock, Short Term Mechanical Circulatory Support, Shock Team
- Trial name
- CASHMERE (NCT05309980)
- Testing
- standard of care
- Where
- France
- Volunteers
- 250 people
- Sponsor
- University Hospital, Bordeaux
Coronary Artery Disease, Heart Failure
PULsecath mechanicaL Support Evaluation
The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes.
- Conditions
- Coronary Artery Disease, Heart Failure, Cardiogenic Shock
- Trial name
- PULSE (NCT03200990)
- Testing
- iVAC2L pVAD
- Where
- 3 sites in France, Netherlands and 1 more
- Volunteers
- 32 people
- Sponsor
- Erasmus Medical Center
Heart Failure
Physiological Control for Mechanical Circulatory Devices
Aim of this clinical study is to compare our newly developed control algorithms for mechanical circulatory support devices based on physiological demand with the standard manual LVAD speed operation.
- Trial name
- REGALVAD (NCT04786236)
- Testing
- Physiological Control Module for the Medtronic -"HVAD" Left Ventricular Assist Device
- Where
- Austria
- Volunteers
- 7 people
- Sponsor
- Heinrich Schima
Ventricular Tachycardia
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.
- Trial name
- PERMIT1 (NCT01294267)
- Testing
- Circulatory Support System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Vivek Reddy
Mechanical Circulatory Support
BRAIN-HEART Ultrasound Study Normative Values for Transcranial Doppler Based Cerebral Blood Flow Assessment
There is a dire need to establish normative values for transcranial Doppler(TCD) derived cerebral blood flow parameters for each type of Mechanical circulatory support (MCS) device and explore the relationship between the MCS…
- Trial name
- MCS (NCT05924503)
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Wake Forest University Health Sciences
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
A prospective, multi-center, open label, randomized controlled, superiority trial to compare clinical outcomes between routine distal perfusion catheter (DPC) insertion versus provisional distal perfusion catheter (DPC) insertion…
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall, Congestive Heart Failure, Myocarditis
- Trial name
- PERFUSE-MCS (NCT07482865)
- Testing
- Distal perfusion catheter insertion
- Where
- 6 sites in South Korea
- Volunteers
- 500 people
- Sponsor
- Samsung Medical Center
Cardiogenic Shock, PCI Patients
Clinical Outcomes of Contemporary IMPELLA Devices in Cardiogenic Shock and High-risk Percutaneous Coronary Intervention
The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI.
- Conditions
- Cardiogenic Shock, PCI Patients, Mechanical Circulatory Support
- Trial name
- IMMERGE (NCT06690567)
- Testing
- Impella implantation
- Where
- Italy
- Volunteers
- 700 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Coronary Artery Disease, High Risk Percutaneous Coronary Intervention
Pivotal Study of the SUpira System in Patients Undergoing High-Risk Percutaneous COronaRy InTervention (HRPCI)
The objective of this study is to assess the safety and efficacy of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing HRPCI.
- Conditions
- Coronary Artery Disease, High Risk Percutaneous Coronary Intervention, Interventional Cardiology, Mechanical Circulatory Support
- Trial name
- SUPPORT II (NCT07296744)
- Testing
- The Supira System, Impella
- Where
- 25 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Patient Comfort, Anxiety
Family Support Weaning from Mechanical Ventilation in Cardiovascular Surgery
Mechanical ventilation support is used to ensure airway clarity in patients after surgery.If patients are not informed about mechanical ventilation treatment in the pre -operation period, panic, anxiety and comfort may be…
- Conditions
- Patient Comfort, Anxiety, Patient Satisfaction
- Trial name
- NCT05820789
- Testing
- Family support
- Where
- Turkey (Türkiye)
- Volunteers
- 40 people
- Sponsor
- Kastamonu University
Heart Failure, Cardiogenic Shock
Registry for Cardiogenic Shock: Utility and Efficacy of Device Therapy
The purpose of this study is to gather information on patients who have heart failure and are eligible for one of the following two procedures: 1) mechanical support, i.e. ventricular assist device (VAD) or 2) heart transplant.
- Trial name
- RESCUE (NCT02790242)
- Where
- 7 sites in United States
- Volunteers
- 1,089 people
- Sponsor
- Columbia University
Coronary Artery Disease
Vortex - Temporary Percutaneous, Transvalvular Circulatory Support System Feasibility Study
Vortex - First in Human study to evaluate the feasibility, safety, clinical and technical success of the Vortex temporary percutaneous, transvalvular circulatory support system (Vortex System)
- Trial name
- Vortex-FIH (NCT04674111)
- Testing
- Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)
- Where
- 2 sites in Australia, Sweden
- Volunteers
- 5 people
- Sponsor
- Boston Scientific Corporation
Heart Failure, Cardiorenal Syndrome
Diuretics Alone vs. Aortix Endovascular Device for Acute Heart Failure
Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) and have persistent congestion despite usual medical therapy.
- Conditions
- Heart Failure, Cardiorenal Syndrome, Cardio-Renal Syndrome, ADHF
- Trial name
- DRAIN-HF (NCT05677100)
- Testing
- Aortix System
- Where
- 50 sites in United States, Hungary
- Volunteers
- 320 people
- Sponsor
- Procyrion
Coronary Artery Disease
Angioshield First-In-Human Study to Demonstrate the Preliminary Safety and Efficacy
The purpose of this study is to determine whether or not the Angioshield device can be safely applied to support saphenous vein grafts used in standard coronary bypass surgery.
- Trial name
- NCT02072239
- Testing
- Angioshield
- Where
- Poland
- Volunteers
- 13 people
- Sponsor
- Neograft Technologies, Incorporated
Heart Diseases, Left Ventricular Dysfunction
InterventiOn of Biventricular Pacemaker Function on ventrIcular Function Among Patients With LVAD's
The primary reason the investigators are doing this study are to understand how the right side of the heart functions in heart failure patients with left ventricular assist devices (LVADs, or "mechanical hearts").
- Trial name
- ROBIN (NCT03232736)
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Advanced Left Ventricular Heart Failure
Corheart 6 LVAS Clinical Investigation
To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.
- Trial name
- NCT07700810
- Testing
- Corheart 6 LVAS
- Volunteers
- 100 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure
Identifying and Facilitating Ventricular Recovery on Mechanical Support
Heart failure is a progressive disorder in which the weakened heart is not able to efficiently pump blood throughout the body. When the body's cells do not receive enough blood, this can result in fatigue, shortness of breath…
- Trial name
- RECOVER (NCT00687856)
- Testing
- Echocardiogram (echo)
- Where
- 5 sites in United States
- Volunteers
- 211 people
- Sponsor
- University of Pittsburgh
Cardiogenic Shock
Cardiogenic Shock Working Group Registry
The Cardiogenic Shock Working Group is a multicenter registry where we collect de-identified clinical variables from the medical records and follow-up phone calls of shock patients from multiple institutions and centralize this…
- Trial name
- CSWG (NCT04682483)
- Testing
- Vasopressor, Inotrope, Acute Mechanical Circulatory Support Devices
- Where
- 16 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Tufts Medical Center