Clinical trials: Heart-Assist Devices
Left Ventricular Assist Device, Heart Failure
Pulse Wave Analysis in Advanced Heart Failure
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.
- Conditions
- Left Ventricular Assist Device, Heart Failure, Intra-aortic Balloon Pump, LVAD Clot
- Trial name
- PWA-HF (NCT01642927)
- Where
- United States
- Sponsor
- University of Minnesota
Exercise Capacity, Quality of Life
Rehabilitation and Outcome for Patients on LVAD Support
A prospective, multi-module intervention based on nutrition management, psychosocial support, and a controlled home-based physical exercise training program for patients on LVAD- support will be provided to improve outcomes in…
- Trial name
- NCT00781807
- Testing
- multi-module rehabilitation program
- Where
- 2 sites in Germany
- Volunteers
- 80 people
- Sponsor
- Hannover Medical School
Myocardial Infarction, Percutaneous Coronary Intervention
Text Message Intervention to Improve Cardiac Rehab Participation
Cardiac rehabilitation (CR) is strongly recommended for patients with coronary heart disease. However, patient enrollment and completion of cardiac rehabilitation is low.
- Conditions
- Myocardial Infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Surgery, Heart Valve Repair or Replacement
- Trial name
- NCT03346278
- Testing
- Text Messaging Intervention
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Washington
Refractory Heart Failure
Levacor™ Ventricular Assist Device (VAD) Bridge to Transplant Study
The Levacor™ Ventricular Assist Device (VAD) has been designed for mechanical circulatory support in heart failure patients. The purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant…
- Trial name
- NCT01001793
- Testing
- Levacor Ventricular Assist Device
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- World Heart Corporation
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
HeartMate II Pump Thrombosis
PREVENtion of HeartMate II Pump Thrombosis
The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.
- Trial name
- PREVENT (NCT02158403)
- Testing
- Clinical Management Recommendations for reducing pump thrombosis
- Where
- 23 sites in United States
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Aortic Valve Regurgitation, Aortic Valve Disease Mixed
JOURNEY LVAD: JOURNEY Left Ventricular Assist Device
The objective of this study is to assess the safety and effectiveness of the J-Valve Transfemoral Transcatheter Heart Valve System in patients on left ventricular assist device (LVAD) support with significant native aortic valve…
- Conditions
- Aortic Valve Regurgitation, Aortic Valve Disease Mixed, Aortic Insufficiency
- Trial name
- NCT07363473
- Testing
- J-Valve Transfemoral System
- Volunteers
- 50 people
- Sponsor
- JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
Infective Endocarditis, Infection Related to Ventricular Assist Device
Retrospective Analysis of Nephrotoxicity During Daptomycin Versus Vancomycin Treatments in High Risk Patients
Acute kidney injury (AKI) is a frequent complication that occurs in 15 to 25% of patients after vascular surgery, and up to 40% of patients after cardiac surgery.
- Conditions
- Infective Endocarditis, Infection Related to Ventricular Assist Device, Infection Related to Vascular Prothesis, Surgical Site Infection
- Trial name
- DVN (NCT03961503)
- Testing
- Daptomycin (DAP) treatment, Vancomycin (VAN) treatment
- Where
- France
- Volunteers
- 72 people
- Sponsor
- University Hospital, Montpellier
Left Ventricular Assist Device, Prognosis
PROgnostic Value of Exercise Capacity Measured as Peak Oxygen Uptake (pVO2) in Recipients of Left Ventricular Assist Devices
Pooling of earlier VO2-studies conducted at the dept. of cardiology, Rigshospitalet, Denmark, and all LVAD centres of the World that wish to participate.
- Conditions
- Left Ventricular Assist Device, Prognosis, Advanced Heart Failure
- Trial name
- PRO-VAD (NCT04423562)
- Testing
- No intervention
- Where
- Denmark
- Volunteers
- 500 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Atrial Fibrillation, Left Ventricular Failure
Non-invasive Blood Pressure and Cardiac Output Measurement by Using Applanation Tonometry
To evaluate and to validate accuracy, precision and trending ability of blood pressure and cardiac output measurement by applanation tonometry in cardiological patients having: atrial fibrillation severe impaired leftventricular…
- Conditions
- Atrial Fibrillation, Left Ventricular Failure, Left Ventricular Impaired Function, Aortic Valve Stenosis
- Trial name
- NCT02444104
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
End-stage Heart Failure
Long-Term Survival After LVAD Implantation in End-Stage Heart Failure
This is a prospective, observational, multi-center cohort study designed to evaluate long-term survival and clinical outcomes in patients with end-stage heart failure undergoing left ventricular assist device (LVAD) implantation.
- Trial name
- NCT07382284
- Testing
- Left Ventricular Assist Device (LVAD) implantation
- Where
- China
- Volunteers
- 300 people
- Sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Advanced Heart Failure
Hong Kong and Taiwan HM3 PMS
Hong Kong and Taiwan HM3 PMS is a prospective, single arm, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04703855
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 3 sites in Hong Kong, Taiwan
- Volunteers
- 3 people
- Sponsor
- Abbott Medical Devices
Congestive Heart Failure
The Epidemiology of Ventricular Assist Device-Related Infections
Infections often occur after ventricular assist devices (VADs) are placed. These infections can be very serious. The goal of this study is to understand why these infections occur.
- Trial name
- NCT01471795
- Where
- 13 sites in United States
- Volunteers
- 150 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Heart Failure.
The Increase Study. Effect of Incremental Versus Fixed Pump on Peak Oxygen Consumption in Heart Failure Patients Supported With a Continuous Flow Left Venticular Assist Device
The purpose of the study is to examine the relationship between working capacity (peak oxygen consumption) and pump speed of continuous flow left ventricular assist devices (CF-LVADs)in heart failure patients.
- Trial name
- NCT01698398
- Testing
- Incremental pump speed of CF-LVAD.
- Where
- Denmark
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Stable Angina, Unstable Angina
Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device
Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is…
- Conditions
- Stable Angina, Unstable Angina, NSTEMI
- Trial name
- AutocathFFR (NCT04861519)
- Testing
- Collecting invasive FFR measurements.
- Where
- 3 sites in Israel
- Volunteers
- 308 people
- Sponsor
- Medhub Ltd.
End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT)
Development & Testing of a Decision Aid for LVAD Placement
The goal of this project is to develop a patient-centered decision aid for decision-making about end-stage heart failure treatment.
- Conditions
- End-Stage Heart Failure, Bridge-to-Transplant LVAD Placement (BTT), Destination Therapy LVAD Placement (DT), Refusal of LVAD Placement (Decliners)
- Trial name
- VADDA (NCT02248974)
- Testing
- LVAD Decision Aid
- Where
- 7 sites in United States
- Volunteers
- 98 people
- Sponsor
- Baylor College of Medicine
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.
Congestive Heart Failure
The Epidemiology of Bleeding and Clotting in Patients Undergoing Heart Transplantation, Coronary Artery Bypass Graft Surgery,or Implantation of Left Ventricular Assist Devices
The purpose of this study is to obtain data or information on how blood clotting factors are activated during open heart surgery.
- Trial name
- NCT01481012
- Where
- 13 sites in United States
- Volunteers
- 94 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Hypertension, Pulmonary, Ventricular Dysfunction, Left
Confirmatory Study of IK-3001 in Japanese Subjects With Peri-/Post-op Pulmonary Hypertension Assoc. With Cardiac Surgery
Sixteen Japanese subjects (6 adults/10 children) with peri- and post-operative pulmonary hypertension associated with cardiac surgery will be evaluated at approx. 6 sites for safety and efficacy of IK-3001.
- Trial name
- NCT01959828
- Testing
- IK-3001
- Where
- 7 sites in Japan
- Volunteers
- 18 people
- Sponsor
- Mallinckrodt
Heart Failure, Cardiovascular Disease
HeartMate 3 ELEVATE™ Registry
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
- Conditions
- Heart Failure, Cardiovascular Disease, Ventricular Dysfunction
- Trial name
- ELEVATE™ (NCT02497950)
- Testing
- HeartMate 3
- Where
- 26 sites in Austria, Czechia and 9 more
- Volunteers
- 540 people
- Sponsor
- Abbott Medical Devices