Clinical trials: Mechanical Circulatory Support
AKI, Renal Replacement Therapy
Hyperoxia vs Normoxia During Cardiopulmonary Bypass
This single-center randomized controlled pilot trial evaluates the effects of intraoperative hyperoxia compared with normoxia during cardiopulmonary bypass (CPB) in adult patients undergoing elective cardiac surgery.
- Conditions
- AKI, Renal Replacement Therapy, NGAL, Arrythmia
- Trial name
- IPEROXIA (NCT07510672)
- Testing
- Hyperoxia group, Normoxia group (control)
- Where
- Italy
- Volunteers
- 104 people
- Sponsor
- University of Padova
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, 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
Cardiogenic Shock, Heart Failure
CORTISHOCK-P: Trial of Corticosteroids in Inflammation-Enriched Heart Failure Cardiogenic Shock
This pilot study investigates whether giving a short course of intravenous corticosteroids (methylprednisolone) alongside standard medical care can help patients recovering from heart failure-related cardiogenic shock.
- Conditions
- Cardiogenic Shock, Heart Failure, Inflammation
- Trial name
- CORTISHOCK-P (NCT07461961)
- Testing
- Methylprednisone, Standard of Care (SOC)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Brigham and Women's Hospital
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Routine Microaxial Heart Pump Support and Protocolized Pulmonary Artery Catheter Monitoring Versus Standard Care in Heart Attack-Related Cardiogenic Shock
The goal of this clinical trial is to learn which treatment strategies improve survival in adult patients with acute myocardial infarction complicated by cardiogenic shock (AMI-CS).
- Conditions
- Cardiogenic Shock, Acute Myocardial Infarction (AMI), Heart Failure, Acute
- Trial name
- DOUBLE-SHOCK (NCT07762560)
- Testing
- Microaxial flow pump (left ventricular assist device), Pulmonary artery catheter, Conventional hemodynamic monitoring
- Where
- Germany
- Volunteers
- 780 people
- Sponsor
- Leipzig Heart Science gGmbH
Congenital Heart Disease
Application of a Clinical Decision Support System to Reduce Mechanical Ventilation Duration After Cardiac Surgery in Children
The goal of this study is to evaluate the impact of a clinical decision support system (CDSS) in children receiving mechanical ventilation (MV) after surgery for congenital heart disease (CHD).
- Trial name
- NCT05687292
- Testing
- Clinical decision support system (CDSS) for ventilator weaning
- Where
- United States
- Volunteers
- 330 people
- Sponsor
- Boston Children's Hospital
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
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
Respiratory Failure, Cardiac Failure
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects on Cardiac Performance
Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm.
- Trial name
- NCT00647361
- Testing
- Neurally adjusted ventilatory assist (NAVA) provided by a commercially available mechanical ventilator (Servo i, Maquet Critical Care, Solna, Sweden).
- Where
- Switzerland
- Volunteers
- 15 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Heart Failure, Cardiovascular Diseases
Anti-thrombotic Monotherapy With the HeartMate 3 LVAS
The purpose of this study is to obtain a single-center safety and feasibility data on patients managed with a single anti-thrombotic therapy and the incidence of thrombotic adverse events associated with HeartMate 3 LVAS therapy.
- Trial name
- NCT03704220
- Testing
- Warfarin
- Where
- Czechia
- Volunteers
- 10 people
- Sponsor
- Institute for Clinical and Experimental Medicine
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
End-stage Heart Failure
Corheart 6 Left Ventricular Assist System Prospective, Multicenter, Single-arm Clinical Evaluation Trial
This study is to evaluate the safety and effectiveness of the Corheart 6 Left Ventricular Assist System (Corheart 6 LVAS) used for the treatment of end-stage heart failure.
- Trial name
- NCT05353816
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- 11 sites in China
- Volunteers
- 50 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
ECMO, Cardiogenic Shock
The ECMOCYP (cytochromes P450 Activity) Study
Prospective open label observational study including patients requiring a tMCS (VA-ECMO or Impella® CP) or in in cardiogenic shock according to the SCAI (Society for Cardiovascular Angiography and Interventions) ESC (European…
- Conditions
- ECMO, Cardiogenic Shock, Temporary Mechanical Circulatory Support
- Trial name
- NCT06662084
- Testing
- phenotype
- Where
- Switzerland
- Volunteers
- 46 people
- Sponsor
- University Hospital, Geneva
End-stage Heart Failure, Left Ventricular Assist Device
LVAD Index and Clinical Outcomes in Continuous-Flow LVAD Patients
This single-center, observational study evaluated the LVAD index, defined as device-estimated pump flow divided by body surface area, in adult patients supported with continuous-flow left ventricular assist devices.
- Conditions
- End-stage Heart Failure, Left Ventricular Assist Device, Mechanical Circulatory Support
- Trial name
- LVAD-INDEX (NCT07633535)
- Testing
- HeartWare Ventricular Assist Device, HeartMate 3 Left Ventricular Assist Device
- Where
- Turkey (Türkiye)
- Volunteers
- 34 people
- Sponsor
- Gaziantep City Hospital
Heart Failure
SUSTAIN-IT: Sustaining Quality of Life of the Aged: Heart Transplant or Mechanical Support?
The purpose of this study is to compare health-related quality of life (HRQOL) outcomes in older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation (HT) or mechanical circulatory support (MCS) as…
- Trial name
- SUSTAIN-IT (NCT02568930)
- Where
- 13 sites in United States
- Volunteers
- 694 people
- Sponsor
- Northwestern University
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.
Cardiogenic Shock
The Current Status and Clinical Outcomes of Patients With Cardiogenic Shock II
The investigation of patient characteristics and prognostic factors of the patients presented with cardiogenic shock (CS) will guide us to identify the better management strategy for these critically ill patients.
- Trial name
- RESCUE II (NCT04143893)
- Testing
- Mechanical circulatory support, Optimal medical treatment
- Where
- South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
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)
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
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