Clinical trials: Advanced Heart Failure, open to volunteers
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
Heart Failure, Heart Transplantation
Electronic Register on Advanced Heart Failure and Transplantation di Cuore
The goal of this observational study is to create an electronic registry of patients diagnosed with Advanced Heart Failure or Heart Transplant, starting from 01/01/1985 and to assess the incidence of Advanced Heart Failure and…
- Trial name
- NCT06773611
- Where
- Italy
- Volunteers
- 10,000 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Ventricular Assist Device, Advanced Heart Failure
Multi-Site Feasibility Testing of the Ventricular Assist Device Anticipatory Guidance Tool
There are a variety of educational documents available to help in a participant's decision for VAD implant, however there is little information available to potential participants to help understand areas of satisfaction and…
- Conditions
- Ventricular Assist Device, Advanced Heart Failure, Anticipatory Guidance
- Trial name
- NCT06823583
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Bryan Heart
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
Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure
Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease
This is a multi-center, observational cohort study including patients with prior coronary artery bypass grafting (CABG) and ≥1 saphenous vein grafts (SVG) presenting with recurrent ischemic symptoms.
- Conditions
- Recurrent Angina After Coronary Artery Bypass Graft, Graft Failure, Coronary Artery Disease Progression
- Trial name
- VIADUCT (NCT04772768)
- Where
- Netherlands
- Volunteers
- 500 people
- Sponsor
- Amsterdam UMC, location VUmc
Congenital Heart Disease, Advanced Heart Failure
TORCH-LATAM-003: Regional Advanced-Therapy Pathways for Congenital Heart Disease
TORCH-LATAM-003 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for children and adults with congenital heart disease and advanced cardiac and/or respiratory failure who may require heart…
- Conditions
- Congenital Heart Disease, Advanced Heart Failure, Respiratory Failure, Heart Transplantation
- Trial name
- TORCH-003 (NCT07837024)
- Testing
- TORCH Congenital Advanced Therapies Pathway (TORCH-CATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Advanced Heart Failure
A Prospective, Multicenter,Single-arm Study of DuoCor 2 Ventricular Assist System for the Treatment of Advanced Biventricular Heart Failure
The objective of this clinical investigation is to evaluate the safety and efficacy of the DuoCor 2 Ventricular Assist System (DuoCor 2 VAS) in subjects with advanced biventricular heart failure requiring circulatory support.
- Trial name
- NCT07757451
- Testing
- DuoCor 2 Ventricular Assist System (DuoCor 2 VAS)
- Where
- China
- Volunteers
- 64 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure, Heart Failure and Reduced Ejection Fraction
Biomarkers for Left Ventricular Reverse Remodeling in Heart Failure (REVERT-HF)
Heart failure is a serious condition where the heart cannot pump blood effectively. Some patients with severe heart failure (known as heart failure with reduced ejection fraction, or HFrEF) can experience significant improvement…
- Trial name
- REVERT-HF (NCT07701876)
- Where
- China
- Volunteers
- 1,740 people
- Sponsor
- Ruijin Hospital Luwan Branch
Advanced Heart Failure, Ischemic Heart Failure
HiCM-188 Cell Therapy in Adults With Advanced Heart Failure Undergoing Heart Bypass Surgery
This clinical study will evaluate the safety and tolerability of HiCM-188, an investigational allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocyte therapy, in adults with advanced heart failure who are undergoing…
- Trial name
- NCT07646210
- Testing
- HiCM-188 Cells
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- HELP Therapeutics Co., Ltd.
Heart Failure, Cardiogenic Shock
Oxygen Delivery Index (ODIN) Study
The objective of this study is to test the feasibility and efficacy of a novel, non-invasive electronic device to monitor the adequacy of tissue perfusion in patients with advanced heart failure or cardiogenic shock in the ICU.
- Trial name
- NCT07601828
- Testing
- Oxygen Delivery Index (ODIN) Device
- Volunteers
- 30 people
- Sponsor
- NYU Langone Health
Insuficiência Cardíaca, Transplante Cardíaco
Effects of Physical Training in Patients With Advanced Heart Failure
Heart failure is a condition where the heart cannot pump blood effectively. This can happen due to changes in the heart's structure or function, leading to symptoms like shortness of breath, fatigue, and reduced ability to…
- Conditions
- Insuficiência Cardíaca, Transplante Cardíaco, Exercício Físico
- Trial name
- NCT07501143
- Testing
- physical training
- Where
- Brazil
- Volunteers
- 22 people
- Sponsor
- University of Nove de Julho
Heart Failure
Corheart 6 LVAS Long-term Follow-up Study
The purpose of this clinical study is to explore the long-term efficacy and safety of the Corheart 6 Left Ventricular Assist System (LVAS) as a treatment for patients with advanced heart failure.
- Trial name
- NCT06267612
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Advanced Heart Failure
Conservative Management of Left Ventricular Assist Device Candidates
Left ventricular assist device (LVAD) candidates will be comprehensively evaluated at our center, including clinical evaluation, echocardiography, right heart catheterization, cardiopulmonary exercise test and laboratory exams.
- Trial name
- NCT05271214
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Tel-Aviv Sourasky Medical Center
Heart Failure
RADIATE-HF - Efficacy and Safety of Cardiac Radiation in Advanced Heart Failure
The RADIATE-HF study is a prospective, interventional, single-center, open-label, non-randomized study conducted at the Rennes University Hospital.
- Trial name
- RADIATE-HF (NCT07770230)
- Testing
- Low-dose cardiac radiation therapy (5 Gy)
- Where
- France
- Volunteers
- 20 people
- Sponsor
- Rennes University Hospital
Advanced Left Ventricular Heart Failure
Corheart 6 LVAS Clinical Investigation
To evaluate the safety and effectiveness of the Corheart 6 left ventricular assist system in providing mechanical support for blood circulation in patients with advanced left ventricular heart failure.
- Trial name
- NCT07700810
- Testing
- Corheart 6 LVAS
- Volunteers
- 100 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure
Aeson TAH System - Post-Market Clinical Follow-up Study
The safety and performance of the Aeson TAH system have been demonstrated for the CE mark approval in December 2020. The purpose of this post-market clinical investigation is to confirm the safety, performance and effectiveness…
- Trial name
- NCT05474092
- Testing
- Aeson Total Artificial Heart
- Where
- Germany
- Volunteers
- 95 people
- Sponsor
- Carmat SAS
Bleeding, Clot Blood
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
Heart failure is a world epidemic. LVADs are increasingly used as they have demonstrated improved survival rates compared to optimal medical management.
- Trial name
- NCT06655376
- Testing
- Aspirin, Warfarin
- Where
- 3 sites in United States
- Volunteers
- 128 people
- Sponsor
- Columbia University
Refractory Heart Failure
Corheart 6 LVAS Study
The primary objective of this study is to evaluate the safety and effectiveness of the Corheart 6 LVAS when used for the treatment of advanced left ventricular heart failure in a European population at 6 months post-implantation.
- Trial name
- NCT05876000
- Testing
- Corheart 6 Left Ventricular Assist System
- Where
- 11 sites in Austria, Germany and 1 more
- Volunteers
- 53 people
- Sponsor
- Shenzhen Core Medical Technology CO.,LTD.
Heart Failure
A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System
The objective of this study is to evaluate the safety and performance of the V-LAP System in subjects with New York Heart Association (NYHA) functional class II and III HF, irrespective of left ventricular ejection fraction.
- Trial name
- NCT06147336
- Testing
- V-LAP™ SYSTEM
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vectorious Medical Technologies Ltd.
Heart Failure With Reduced Ejection Fraction (HFrEF)
A Study to Evaluate the Safety and Efficacy of AC01 Compared to Placebo in Participants With Chronic Heart Failure
The primary purpose of the study is to evaluate the safety and efficacy of 2 doses of AC01 compared to placebo over 12 weeks in participants with chronic advanced HFrEF.
- Trial name
- GOAL-HF2 (NCT07584967)
- Testing
- AC01
- Volunteers
- 400 people
- Sponsor
- AnaCardio AB