Clinical trials: Advanced Heart Failure
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
Mitral Valve Insufficiency, Heart Failure
Effectiveness of Surgical Mitral Valve Repair Versus Medical Treatment for People With Significant Mitral Regurgitation and Non-ischemic Congestive Heart Failure
Mitral regurgitation (MR), also known as mitral insufficiency, is a condition in which the heart's mitral valve, located between two of the heart's main chambers, does not firmly shut, allowing blood to leak backwards within the…
- Trial name
- SMMART-HF (NCT00608140)
- Testing
- Surgical mitral valvuloplasty with placement of annular ring (SMVR), Optimal medical therapy (OMT)
- Where
- 9 sites in United States, Canada
- Volunteers
- 2 people
- Sponsor
- Duke University
Heart Failure
A Clinical Trial to Evaluate the HeartWare MVAD® System (MVAdvantage)
This multi-center, prospective, non-randomized, single-arm trial will investigate the safety and performance of the HeartWare® Miniaturized Ventricular Assist Device (MVAD®) system over 24 months in subjects with advanced heart…
- Trial name
- NCT01831544
- Testing
- HeartWare MVAD® System
- Where
- 11 sites in Australia, Austria and 3 more
- Volunteers
- 11 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure NYHA Class III, Heart Failure NYHA Class IV
Family Palliative and End-of-Life Care for Advanced Heart Failure
Overall objective is to test whether the 5-weekly family home palliative and end-of-life care (FamPALcare) intervention educational and supportive sessions will improve rural home end-of-life and palliative care (EOLPC) for…
- Trial name
- NCT04153890
- Testing
- FamPALcare
- Where
- United States
- Volunteers
- 78 people
- Sponsor
- West Virginia University
Left Sided Heart Failure
HW006 LATERAL Thoracotomy
This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for…
- Trial name
- HVAD (NCT02268942)
- Testing
- HeartWare HVAD, Thoracotomy
- Where
- 26 sites in United States, Canada
- Volunteers
- 144 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Chronicle Offers Management to Patients With Advanced Signs and Symptoms of Heart Failure (COMPASS-HF)
COMPASS-HF was a prospective, two-arm, randomized (1:1), multi-center, parallel controlled study. The purpose of the randomized study was to test the safety of an implantable hemodynamic monitor (IHM) and pressure sensor lead.
- Trial name
- NCT00643279
- Testing
- Chronicle Implantable Hemodynamic Monitor, Standard of Care
- Where
- 28 sites in United States
- Volunteers
- 277 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
University of Michigan Advanced Heart Failure Tele-Monitoring and Flexible Diuretic Project
The proposed project is a 2x2 factorial designed study aimed at assessing the impact of 1) a home tele-monitoring system and 2) a flexible diuretic regimen among high risk heart failure patients in the University of Michigan…
- Trial name
- Manifold-HF (NCT02344342)
- Testing
- Telemonitoring, Flexible Diuretic Regimen
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- University of Michigan
Heart Failure
Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.
- Trial name
- NCT03001674
- Testing
- Conductance catheterization
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Tufts Medical Center
Heart Failure
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.
- Trial name
- HW-PAS-03 (NCT01832610)
- Testing
- HeartWare® VAS
- Where
- 25 sites in United States
- Volunteers
- 101 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Heart Failure, Cardiac Decompensation
Global rEgistry on decongestioN Therapy Using Less invasivE UltraFiltration
In patients with advanced volume overload, minimally invasive ultrafiltration treatment in the acute phase can have a positive effect on clinical outcome.
- Conditions
- Acute Heart Failure, Cardiac Decompensation, Volume Overload
- Trial name
- GENTLE-UF (NCT02769351)
- Testing
- periph. minimal invasive ultrafiltration
- Where
- 19 sites in Germany, Sweden and 1 more
- Volunteers
- 104 people
- Sponsor
- Fresenius Medical Care Deutschland GmbH
Chronic Heart Failure
Evaluation of the HeartWare Left Ventricular Assist Device for the Treatment of Advanced Heart Failure
The purpose of this study is to evaluate the safety and effectiveness of the HeartWare® LVAD System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- ADVANCE (NCT00751972)
- Testing
- HeartWare® VAS
- Where
- 35 sites in United States
- Volunteers
- 140 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Depression, Heart Failure
Personalized Treatments for Depressive Symptoms in Patients With Advanced Heart Failure
We are doing this study to help patients, caregivers, and providers make decisions about how best to manage depressive symptoms in advanced heart failure.
- Trial name
- NCT03688100
- Testing
- Behavioral Activation Therapy, Medication Management
- Where
- United States
- Volunteers
- 494 people
- Sponsor
- Cedars-Sinai Medical Center
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Continued Access Protocol
The objective of the study is to continue to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the…
- Trial name
- MOMENTUM 3 CAP (NCT02892955)
- Testing
- HeartMate 3 LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,685 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3™ CE Mark Clinical Investigation Plan
The purpose of this clinical investigation is to evaluate the performance and safety of the HeartMate 3 Left Ventricular Assist System (HM3 LVAS) To support obtaining CE Mark for the HM3 LVAS in Europe, a multi-center clinical…
- Trial name
- HM3 CE Mark (NCT02170363)
- Testing
- Left Ventricular Assist System (LVAS)
- Where
- 10 sites in Australia, Austria and 4 more
- Volunteers
- 50 people
- Sponsor
- Abbott Medical Devices
Chronic Heart Failure
A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL)
This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management.
- Trial name
- DT2 (NCT01966458)
- Testing
- HeartWare® VAS (HVAD), Control LVAD
- Where
- 47 sites in United States
- Volunteers
- 494 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Heart Failure
Clinical Evaluation of HW005 Ventricular Assist System for the Treatment of Advanced Heart Failure in Japan
The purpose of the study is to evaluate the safety and effectiveness of the HW005 System in patients listed for cardiac transplantation with refractory, advanced heart failure at risk of death.
- Trial name
- HW005 (NCT02091440)
- Testing
- Implant of the HW005 Ventricular Assist System.
- Where
- 5 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Advanced Refractory Left Ventricular Heart Failure
HeartMate 3 CE Mark Study Long Term Follow-up
The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS…
- Trial name
- HM3 CE LTFU (NCT03022461)
- Testing
- Long term follow-up
- Where
- 8 sites in Australia, Austria and 4 more
- Volunteers
- 25 people
- Sponsor
- Abbott Medical Devices
Advanced Heart Failure
Post Market Surveillance of the HeartMate 3 Left Ventricular Assist System in Korea
The Korea HM3 PMS is a prospective, single arm, open-label, multi-center, post market surveillance is designed to evaluate clinical and functional outcomes with the HM3 LVAS as a treatment for advanced heart failure.
- Trial name
- NCT04915924
- Testing
- HeartMate 3™ left ventricular assist system (HM3 LVAS)
- Where
- 22 sites in South Korea
- Volunteers
- 358 people
- Sponsor
- Abbott Medical Devices
Hepatitis C, Chronic, Heart Failure
Hepatitis C Virus(HCV) Heart and Lung Study
This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.
- Conditions
- Hepatitis C, Chronic, Heart Failure, Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
- Trial name
- NCT02858180
- Testing
- Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Duke University
Chronic Heart Failure, Atrial Fibrillation
Curing Atrial Fibrillation in Heart Failure
Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF).
- Trial name
- NCT00292162
- Testing
- radiofrequency ablation, ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril, Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol
- Where
- United Kingdom
- Volunteers
- 41 people
- Sponsor
- NHS Greater Glasgow and Clyde