Clinical trials: Ventricular Assist Device
High-risk Percutaneous Coronary Intervention
Magenta Elevate™ EFS in High-Risk PCI Patients
The Elevate™ EFS study is designed to evaluate the safety and feasibility of the Magenta Elevate™ percutaneous Left Ventricular Assist Device (pLVAD) System in patients undergoing non-emergent, high-risk percutaneous coronary…
- Trial name
- NCT05727059
- Testing
- The Elevate™ System
- Where
- 2 sites in United States
- Volunteers
- 18 people
- Sponsor
- Magenta Medical Ltd.
Left Ventricular Assist Device, Physical Therapy
The Effect of Physical Therapy Intervention in Patients With Left Ventricular Assistive Device on Physical Function
To retrospectively investigate the effect of physical therapy intervention on improving physical function of patients post left ventricular assist device (LVAD) through electronic medical record survey
- Trial name
- LVAD (NCT03636815)
- Testing
- physical therapy
- Where
- Taiwan
- Volunteers
- 62 people
- Sponsor
- National Taiwan University Hospital
Heart Failure, Advanced Heart Failure
REACTION-VAD Trial: Remote Exercise Training Via Telemedicine in Patients With Long-Term Ventricular Assist Devices
Current international guidelines recommend that patients with a heart pump (left ventricular assist device, LVAD) participate in supervised exercise cardiac rehabilitation programs.
- Conditions
- Heart Failure, Advanced Heart Failure, Left Ventricular Assist Device, LVAD
- Trial name
- REACTION-VAD (NCT07611188)
- Testing
- Remote Physical Conditioning Program (Telerehabilitation), Usual care. No Remote Monitoring.
- Where
- 10 sites in Spain
- Volunteers
- 78 people
- Sponsor
- Puerta de Hierro University Hospital
Heart Failure, End-stage Disease
Proactive Palliative Care for Patients With Ventricular Assist Devices (VAD) and Their Families
The primary aim of the study is to provide "proof of concept" to demonstrate that patients with Ventricular Assist Devices (VADs) and caregivers are willing to be enrolled in a randomized trial of palliative care and that such a…
- Trial name
- NCT01427634
- Testing
- Palliative Care, Usual Care
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
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
Coronary Artery Disease
CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs to inform device design and finalization.
- Trial name
- NCT05695716
- Testing
- CSI pVAD System
- Where
- Georgia
- Volunteers
- healthy volunteers welcome
- Sponsor
- Abbott Medical Devices
Cardiogenic Shock
Evaluation of the Efficacy of Early Implantation of a Percutaneous Left Ventricular Assist Devices in Acute Coronary Syndrome Complicated by Cardiogenic Shock Compared to Conventional Therapy: a Prospective, Multicenter, Randomized, Controlled and Open-label Clinical Trial
The ULYSS study is a randomized, multicenter, interventional and prospective open-label clinical trial. It aims to evaluate the efficacy of the addition of an early IMPELLA CP support on top of optimal medical therapy and culprit…
- Trial name
- ULYSS (NCT05366452)
- Testing
- IMPELLA CP, Conventional therapy
- Where
- France
- Volunteers
- 204 people
- Sponsor
- Assistance Publique Hopitaux De Marseille
Failing Fontan Physiology, Failing Fontan
The Destination Therapy Evaluation for Failing Fontan Study
Purpose: The purpose of the Destination Therapy Evaluation for Failing Fontan Study (DEFINe Study) is to perform a single center physician-investigator led feasibility study to initiate examination of the safety and efficacy of…
- Conditions
- Failing Fontan Physiology, Failing Fontan, Single-ventricle, Single-ventricle Fontan
- Trial name
- DEFINe (NCT01149603)
- Testing
- HeartMate II Ventricular Assist Device
- Where
- United States
- Sponsor
- Timothy Icenogle, MD
Heart Rate, Chronotropic Incompetence
Pacing in Left Ventricular Assist Device Recipients
Implantation with left ventricular assist device (LVAD) in patients with end-stage heart failure (HF) leads to improvements in survival and quality of life, however, work capacity remains disappointingly low, at half of the…
- Conditions
- Heart Rate, Chronotropic Incompetence, Pacing
- Trial name
- Pace-VAD (NCT03844516)
- Testing
- Peak oxygen uptake test with pacing, Peak oxygen uptake test without pacing
- Where
- Denmark
- Volunteers
- 15 people
- Sponsor
- Finn Gustafsson
Acute on Chronic Systolic Congestive Heart Failure, Cardiorenal Syndrome
Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD
Cardiovascular disease is the leading cause of mortality in the US, accounting for 45% of all deaths. Chronic Heart Failure (CHF) is now understood to be a multi-system disease process involving not only the cardiovascular system…
- Trial name
- NEUTRALIZE-CRS (NCT03836482)
- Testing
- Selective Cytopheretic Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- SeaStar Medical
Driveline Heart-assisted Device Related Infection
Driveline Silicone Skin Interface Registry
The purpose of this observational registry is to determine the freedom from driveline (DL) infection events in subjects implanted with a HeartMate II LVAD in whom only the silicone portion of the DL is externalized resulting in a…
- Trial name
- SSI (NCT01577433)
- Where
- 15 sites in United States
- Volunteers
- 400 people
- Sponsor
- Abbott Medical Devices
Heart Failure
Ventricular Assist Device (VAD) Research Registry and Blood Sub-Study
This study is meant to predict the outcome of VAD therapy, by forming a VAD registry for quality assessment, research, and real-time monitoring of patients on VAD therapy.
- Trial name
- NCT05637242
- Where
- United States
- Volunteers
- 371 people
- Sponsor
- Corewell Health West
Left Ventricular Assist Devices Patients
REVADE : Right Ventricular Function and Exercise in Left Ventricular Assist Device Patients : Echocardiographic Study
Heart failure is a public health problem, responsible for 150.000 admissions, 32.000 deaths, 1% of public health expenditure each year in France.
- Trial name
- REVADE (NCT02067455)
- Testing
- adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography
- Where
- France
- Volunteers
- 12 people
- Sponsor
- Rennes University Hospital
Congestive Heart Failure
Developing and Assessing Competencies for Caregivers and Patients With Ventricular Assist Devices
Discharge to the community is increasingly becoming a priority for patients implanted with a Ventricular Assist Device (VAD). Because VADs are complex, patients and caregivers often fear leaving the hospital, although their…
- Trial name
- NCT00178009
- Testing
- self-paced instruction
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Pittsburgh
High-Risk PCI
SAVE-PCI: NyokAssist™ Small-Bore VAD vs. IABP in Elective High-Risk PCI
SAVE-PCI is a prospective, multi-center, randomized controlled trial evaluating the safety and efficacy of NyokAssist™, a small-bore percutaneous ventricular assist device (pVAD), in comparison with intra-aortic balloon pump…
- Trial name
- NCT07010965
- Testing
- NyokAssist™, IABP Intra-aortic balloon pump
- Where
- 12 sites in China
- Volunteers
- 236 people
- Sponsor
- magAssist, Inc.
Heart Diseases, Coronary Artery Disease (CAD)
Feasibility Study SA of the Supira System for HRPCI
The objective is to assess the feasibility and safety of the Supira System in providing temporary cardiovascular hemodynamic support in patients undergoing high-risk percutaneous interventions (HRPCI).
- Conditions
- Heart Diseases, Coronary Artery Disease (CAD), Heart Failure
- Trial name
- NCT05864248
- Testing
- Supira System
- Where
- 2 sites in Brazil
- Volunteers
- 71 people
- Sponsor
- Supira Medical
LVAD (Left Ventricular Assist Device) Thrombosis, LVAD
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump
This multi-center, prospective, randomized, double-blinded, placebo-controlled study aims to investigate whether withdrawal of aspirin from the antithrombotic regimen in patients supported with the CH-VAD pump is non-inferior to…
- Conditions
- LVAD (Left Ventricular Assist Device) Thrombosis, LVAD, LVAD (Left Ventricular Assist Device), LVAD-related GI Bleed
- Trial name
- STAR (NCT07644247)
- Testing
- Warfarin (INR 2-3) with aspirin
- Volunteers
- 370 people
- Sponsor
- China National Center for Cardiovascular Diseases
Heart Failure
Massage Therapy for Self-efficacy in LVAD Recipients
This pilot study evaluates the role of massage therapy to improve self-efficacy in patients with advanced heart failure who have recently received a left-ventricular assist device.
- Trial name
- NCT04018508
- Testing
- Massage
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Medstar Health Research Institute
End Stage Heart Failure
Impact of LVAD Implantation on Micro- and Macrovascular Function
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions.
- Trial name
- LVAD (NCT02174133)
- Where
- Germany
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Klinik für Kardiologie, Pneumologie und Angiologie
Heart Failure
The ARIES HeartMate 3 Pump IDE Study
Prospective, randomized, double-blinded, placebo-controlled clinical investigation of advanced heart failure patients treated with the HM3 with two different antithrombotic regimens: vitamin K antagonist with aspirin versus…
- Trial name
- NCT04069156
- Testing
- LVAD Implant, Aspirin 100mg
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 628 people
- Sponsor
- Abbott Medical Devices