Clinical trials: Mechanical Circulatory Support, active
Cardiogenic Shock
Polish Nationwide Registry of Diagnostics, Treatment and Outcome in Patients With Cardiogenic Shock
The registry objective is to get information on current epidemiology, diagnostics, treatment and outcome in patients with cardiogenic shock in Poland.
- Trial name
- CaS-POL (NCT06697093)
- Where
- 2 sites in Poland
- Volunteers
- 500 people
- Sponsor
- Wroclaw Medical University
Cardiogenic Shock, Mechanical Circulatory Support
OPTIMIZE 5.5 - Optimizing Impella 5.5 Outcomes Through Advanced Data Science
The main goal of this observational, study is to develop a clinical decision support tool utilizing Impella 5.5 pump parameters to predict native heart recovery and prevent adverse events, by leveraging data science and…
- Conditions
- Cardiogenic Shock, Mechanical Circulatory Support, Cardiogenic Shock Post Myocardial Infarction
- Trial name
- OPTIMIZE (NCT07619144)
- Testing
- Micro-axial flow pump support
- Where
- Austria
- Volunteers
- 100 people
- Sponsor
- Medical University of Vienna
Heart Failure, Cardiogenic Shock
INitiation and Titration of Guideline Directed Medical TheRApy in HearT Failure Cardiogenic Shock With ImpElla 5.5 for Cardiac Recovery
The study will evaluate the impact of a combined device-drug strategy with Impella 5.5 with best practices and optimized GDMT on heart recovery outcomes in patients with decompensated heart failure and cardiogenic shock.
- Conditions
- Heart Failure, Cardiogenic Shock, Reduced Ejection Fraction Heart Failure
- Trial name
- INTeGRATE (NCT06965504)
- Testing
- Impella 5.5 SmartAssist
- Where
- 17 sites in United States
- Volunteers
- 250 people
- Sponsor
- Abiomed Inc.
Cardiogenic Shock Acute, Bypass, Cardiopulmonary
Prognosis of Patients With Mixed Cardiogenic-Vasoplegic Shock
Mixed cardiogenic-vasoplegic shock (M-CS) represents a distinct and severe phenotype of cardiogenic shock characterized by concomitant myocardial dysfunction and inappropriate systemic vasodilation.
- Conditions
- Cardiogenic Shock Acute, Bypass, Cardiopulmonary, Septic Shock, Mechanical Circulatory Support
- Trial name
- PROMIX (NCT07354568)
- Where
- France
- Volunteers
- 2,500 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Cardiogenic Shock Acute, STEMI - ST Elevation Myocardial Infarction
Hong Kong Cardiogenic Shock Initiative
Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is a severe condition with high mortality. Early revascularization and Impella device (Abiomed) support improve outcomes.
- Conditions
- Cardiogenic Shock Acute, STEMI - ST Elevation Myocardial Infarction, Cardiogenic Shock, Cardiogenic Shock Post Myocardial Infarction
- Trial name
- HK CSI (NCT07323238)
- Where
- Hong Kong
- Volunteers
- 320 people
- Sponsor
- Prince of Wales Hospital, Shatin, Hong Kong
Thrombosis, Blood Coagulation Disorder
Dynamics of Platelet Activation in Patients With Ventricular Assist Device (VAD)
Consenting patients with end-stage heart failure that are implanted with/candidates for implant of a short-term/durable mechanical circulatory support device (e.g.: percutaneous microaxial pumps (Impella), extracorporeal membrane…
- Conditions
- Thrombosis, Blood Coagulation Disorder, Platelet Thrombus, Platelet Dysfunction Due to Aspirin
- Trial name
- PASVAD (NCT03255928)
- Testing
- PAS assay, TGT
- Where
- Italy
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Scientific Institute San Raffaele
Cardiogenic Shock
Clinical Effects of Intra-aortic Balloon Support in Early Acute Coronary Syndrome and Non-Acute Coronary Syndrome Related Cardiogenic Shock
The goal of this randomized controlled trial is to appraise the impact of intra-aortic balloon pump (IABP) in the treatment of early stages of cardiogenic shock, irrespective of etiology.
- Trial name
- IABP ON-TIME (NCT06414187)
- Testing
- Intra-Aortic Balloon Pump
- Where
- Netherlands
- Volunteers
- 400 people
- Sponsor
- Erasmus Medical Center
Cardiogenic Shock Acute, Cardiogenic Shock
Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK)
The goal of this observational study is to evaluate the clinical outcomes and management approaches of cardiogenic shock throughout the years in adult patients admitted to a Cardiology Department.
- Conditions
- Cardiogenic Shock Acute, Cardiogenic Shock, Cardiogenic Shock Post Myocardial Infarction
- Trial name
- COR-SHOCK (NCT07597291)
- Where
- Portugal
- Volunteers
- 800 people
- Sponsor
- Hospital de Santa Cruz, Portugal
High-Risk Percutaneous Coronary Intervention
Magenta Elevate™ First-in-Human Clinical Study in High-Risk PCI Patients
The Elevate™ First-In-Human (FIH) study is designed to evaluate the initial safety and device functionality of the Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk…
- Trial name
- ELEVATE I (NCT06099548)
- Testing
- The Elevate™ System
- Where
- 2 sites in Georgia
- Volunteers
- 20 people
- Sponsor
- Magenta Medical Ltd.
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.
Heart Failure, Mechanical Circulatory Support
Cell Therapy and Myocardial Recovery in Heart Failure Patients Undergoing Left Ventricular Assist Device Support
The goal of CELL-VAD Pilot trial is to investigate a personalized stem cell therapy approach for patients with advanced non-ischemic chronic heart failure (NICM) who are supported by LVAD.
- Trial name
- CELL-VAD (NCT06154044)
- Testing
- CD34+ stem cell therapy
- Where
- Slovenia
- Volunteers
- 10 people
- Sponsor
- University Medical Centre Ljubljana
Cardiac Arrest (CA)
Does Increasing the Compression Pause From 3 to 5 Seconds in Mechanical Compression Devices Increase Ventilation Success Rate and Return of Spontaneous Circulation?
To give chest compressions during cardiopulmonary resuscitation (CPR), mechanical chest compression devices can be used. During synchronous 30:2 CPR, the standard setting on these devices leave an automated 3-second chest…
- Trial name
- LUCASVP (NCT06824961)
- Testing
- 5-second ventilation pause duration during mechanical CPR, 3-second ventilation pause duration during mechanical CPR
- Where
- 2 sites in Netherlands
- Volunteers
- 692 people
- Sponsor
- Amsterdam UMC, location VUmc
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.
Heart Failure, Gut Microbiome
Enhanced Nutritional Optimization in LVAD Trial
The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut…
- Conditions
- Heart Failure, Gut Microbiome, Nutritional Deficiency
- Trial name
- ENOL (NCT05655910)
- Testing
- Ensure Surgery Immunonutrition shake
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Columbia University
High-risk PCI, Coronary Artery Disease Risk High
Use of Mechanical Left ventricuLar Unloading in Complex Higher-risk Indicated Procedures
If there is a narrowing or blockage in the coronary arteries of the heart, the cardiologist may choose to treat this blockage. This is called percutaneous coronary intervention (PCI), which involves both balloon angioplasty and…
- Trial name
- UNLOAD-CHIP (NCT07380217)
- Testing
- Mechanical circulatory support with the Pulsecath iVAC2L device
- Where
- 8 sites in Netherlands
- Volunteers
- 98 people
- Sponsor
- Amsterdam UMC, location VUmc
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
- 26 sites in United States
- Volunteers
- 358 people
- Sponsor
- Supira Medical
Cardiogenic Shock
Unloading in Heart Failure Cardiogenic Shock
The purpose of this research study is to evaluate whether timely and aggressive temporary Mechanical Circulatory Support (tMCS) through the Impella 5.5® in patients with acute decompensated heart failure complicated by…
- Trial name
- UNLOAD HF-CS (NCT05064202)
- Testing
- Impella 5.5, Inotropes
- Where
- 5 sites in Netherlands
- Volunteers
- 456 people
- Sponsor
- Amsterdam UMC, location VUmc
Advanced Heart Failure, Acquired Heart Disease
TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease
TORCH-LATAM-004 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for adults with advanced heart failure secondary to acquired or structural heart disease who may require heart or combined…
- Conditions
- Advanced Heart Failure, Acquired Heart Disease, Structural Heart Disease, Heart Transplantation
- Trial name
- TORCH-004 (NCT07826078)
- Testing
- TORCH Adult Advanced Therapies Pathway (TORCH-AATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Advanced Heart Failure, Mechanical Circulatory Support
Palliative Care Intervention to Improve Health Related Quality of Life for Patients on Long-Term LVAD Support
Background: While left ventricular assist device (LVAD) therapy improves survival in patients with advanced heart failure (AHF), unique LVAD-related burdens may impact health-related quality of life (HRQoL).
- Conditions
- Advanced Heart Failure, Mechanical Circulatory Support, Left Ventricular Assist Device, Palliative Care
- Trial name
- PALL-VAD (NCT07445932)
- Testing
- Palliative care intervention
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- Medstar Health Research Institute
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic