Clinical trials: Mechanical Circulatory Support
Coronary Artery Disease, High-risk Percutaneous Coronary Intervention
Early Feasibility Study of the Supira System in Patients Undergoing HRPCI
The objective of this study is to assess the feasibility and safety 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
- Trial name
- NCT06087575
- Testing
- Supira System
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Supira Medical
Heart Failure, Aortic Stenosis
Von Willebrand Factor As a Biological Sensor of Blood Flow in Percutaneous Cardiac Procedure
The WITAVI study was designed to explore the kinetic and associated outcome of Von Willebrand Factor-multimerizaton defects associated with devices in cardiovascular diseases.
- Trial name
- WiTAVi (NCT02628509)
- Testing
- cardiac devices
- Where
- France
- Volunteers
- 500 people
- Sponsor
- University Hospital, Lille
Coronary Artery Disease
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
- Trial name
- NCT05315544
- Testing
- CSI pVAD system
- Where
- Georgia
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Mechanical Ventilation Complication, Congenital Heart Disease
Application of Neurally Adjusted Ventilatory Assist to Children After Congenital Cardiac Surgery
Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort.
- Trial name
- NCT01662011
- Testing
- mode of neurally adjusted ventilatory assist, Mode of pressure support ventilation
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Heart-lung Interaction, Right Ventricular Hypertrophy
Cardiopulmonary Effect of Mechanical Ventilation in Children With Right Ventricular Hypertrophy
Neurally adjusted ventilatory assist (NAVA) is a new mode of mechanical ventilation that delivers ventilatory assist in proportion to neural effort.
- Conditions
- Heart-lung Interaction, Right Ventricular Hypertrophy, Postoperative Care, Congenital Heart Disease
- Trial name
- NCT04825054
- Testing
- Mechanical ventilation with NAVA mode, Mechanical ventilation with PCV mode, Mechanical ventilation with PSV mode
- Where
- 2 sites in China
- Volunteers
- 30 people
- Sponsor
- Limin Zhu
Congenital Heart Disease
Implementing Models for Mechanical Circulatory Support Presurgical Assessment in Congenital Heart Disease Treatment
The purpose of this research study is to look at the advantages of using a 3D printed heart model for surgical planning in children who have been diagnosed with Congenital Heart Disease (CHD) and clinical heart failure and will…
- Trial name
- IMMPACT (NCT03891160)
- Testing
- 3D model of heart
- Where
- 6 sites in United States
- Volunteers
- 36 people
- Sponsor
- Columbia University
Pulmonary Embolism and Thrombosis, Extracorporeal Membrane Oxygenation
Mechanical Respiratory/circulatory Support in Patients with Pulmonary Thrombectomy
Pulmonary embolism (PE) results from embolization of venous thrombi in the branches of the pulmonary arteries. Although anticoagulation is usually the preferred method of treatment, patients with high-risk and/or…
- Conditions
- Pulmonary Embolism and Thrombosis, Extracorporeal Membrane Oxygenation, Percutaneous Pulmonary Thrombectomy
- Trial name
- NCT06525480
- Testing
- Percutaneous pulmonary thrombectomy
- Where
- Spain
- Volunteers
- 77 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
End-stage Heart Failure
Mechanical Circulatory Support Korea Post Market Surveillance Study (PMS)
Medtronic is sponsoring this Mechanical Circulatory Support (MCS) Korea Post-Market Surveillance (PMS) to evaluate the safety and performance of the HeartWare Ventricular Assist Device System (HVAD® System) when used in routine…
- Trial name
- NCT04543747
- Testing
- HeartWare Ventricular Assist Device
- Where
- 2 sites in South Korea
- Volunteers
- 77 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Cardiogenic Shock, Cardiac Arrest
Platelet Function and Impella Support
Mechanical circulatory support (MCS) with the Impella microaxial pump in the setting of cardiogenic shock/cardiac arrest (CS/CA) is accompanied by substantial risk of life-threatening complications, including hemolysis…
- Conditions
- Cardiogenic Shock, Cardiac Arrest, Mechanical Circulatory Support
- Trial name
- IMPELLA-PLT (NCT06487091)
- Testing
- Analysis of platelet function
- Where
- 2 sites in Italy
- Volunteers
- 30 people
- Sponsor
- Università Vita-Salute San Raffaele
Heart Failure With Reduced Ejection Fraction, Endothelial Dysfunction
Endothelial Function in Mechanical Circulatory Support
The pathophysiology of HF is highly variable, with overlapping pathogenic mechanisms that complicates any attempt to create a simple and unified conceptual model.
- Conditions
- Heart Failure With Reduced Ejection Fraction, Endothelial Dysfunction, LVAD
- Trial name
- NCT04539093
- Testing
- Exposure of interest - Use of left ventricular assist device (LVAD)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Medical College of Wisconsin
Coronary Artery Disease
PIvotal Trial of the KARDION Cory P4 MechANical Circulatory SupporT SystEm
This purpose of this trial is to demonstrate 30 day safety and effectiveness outcomes of the KARDION CORY P4 System in subjects who require hemodynamic support during a high-risk PCI procedure.
- Trial name
- NCT06445608
- Testing
- Percutaneous Mechanical Circulatory Support
- Where
- 18 sites in United States
- Volunteers
- 310 people
- Sponsor
- Kardion Inc
Heart Failure, Heart Diseases
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
The purpose of TEAM-HF IDE clinical trial is to evaluate safety and effectiveness of the HeartMate 3 LVAS compared to guideline directed medical therapy (GDMT) in a population of ambulatory advanced heart failure patients who are…
- Conditions
- Heart Failure, Heart Diseases, Cardiovascular Diseases, Pulmonary Hypertension
- Trial name
- TEAM-HF (NCT06526195)
- Testing
- CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
- Where
- 68 sites in United States, Austria and 6 more
- Volunteers
- 850 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Safe Surveillance of PCI Under Mechanical Circulatory Support With the Saranas Early Bird Bleed Monitoring System
The objective of this study is to establish the safety of complex high-risk Percutaneous Coronary Intervention (PCI) using Mechanical Circulatory Support (MCS) and surveillance with the Saranas Early Bird Bleed Monitoring System…
- Trial name
- SAFE-MCS (NCT05077657)
- Testing
- Early Bird® Bleed Monitoring System, Impella®
- Where
- 11 sites in United States
- Volunteers
- 203 people
- Sponsor
- Saranas, Inc.
Coronary Artery Disease
SHIELD II Clinical Investigation
The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with…
- Trial name
- SHIELD II (NCT02468778)
- Testing
- HeartMate PHP, Any Abiomed Impella® device approved for use in high-risk PCI
- Where
- 58 sites in United States
- Volunteers
- 54 people
- Sponsor
- Abbott Medical Devices
Cardiogenic Shock
Lower Silesia Cardiogenic Shock Initiative
LSCSI is a Hub\&Spoke project with the main aim to improve the outcome of patients with cardiogenic shock in Lower Silesia region, Poland.
- Trial name
- LSCSI (NCT05465200)
- Testing
- Structured treatment of cardiogenic shock patients
- Where
- Poland
- Volunteers
- 50 people
- Sponsor
- Wroclaw Medical University
Cardiogenic Shock, Acute Coronary Event
Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age.
- Trial name
- NCT06827314
- Where
- Italy
- Volunteers
- 500 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Coronary Artery Disease, High Risk PCI
CHIP-CC Registry: A Prospective Multicenter Registry of Complex High-Risk PCI in China
This is a prospective, multicenter, observational registry designed to evaluate clinical outcomes in patients undergoing complex high-risk indicated percutaneous coronary intervention (CHIP-PCI) in China.
- Conditions
- Coronary Artery Disease, High Risk PCI, Percutaneous Coronary Intervention (PCI)
- Trial name
- CHIP-CC (NCT07557238)
- Testing
- Percutaneous Coronary Intervention, Mechanical Circulatory Support
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Guofeng Gao
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
Heart Failure，Congestive
Effect of mechanIcal circulatoRy Support ON Exercise Capacity aMong pAtieNts With Heart Failure
This study will evaluate how the cardiovascular system interacts with mechanical hearts to provide blood flow to the body during exercise.
- Trial name
- IRONMAN (NCT03078972)
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
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