Clinical trials: Advanced Heart Failure
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
Advanced Heart Failure, Acquired Heart Disease
TORCH-LATAM-004: Regional Advanced-Therapy Pathways for Adults With Acquired or Structural Heart Disease
TORCH-LATAM-004 is a pragmatic stepped-wedge cluster randomized trial evaluating a regional pathway for adults with advanced heart failure secondary to acquired or structural heart disease who may require heart or combined…
- Conditions
- Advanced Heart Failure, Acquired Heart Disease, Structural Heart Disease, Heart Transplantation
- Trial name
- TORCH-004 (NCT07826078)
- Testing
- TORCH Adult Advanced Therapies Pathway (TORCH-AATP)
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Heart Failure, Cardiomyopathy
Clinical Evaluation on Advanced Resynchronization
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure.
- Trial name
- NCT00658203
- Testing
- New Living CHF
- Where
- 36 sites in France, Germany and 4 more
- Volunteers
- 310 people
- Sponsor
- LivaNova
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
Congestive Heart Failure
The V-Wave Shunt: FIM Safety and Feasibility Study
The V-Wave atrial-septal shunt implant is intended for the reduction of elevated left atrial filling pressures ('Left Atrial Decompression') in chronic, New York Heart Association (NYHA) class III -IV, Heart Failure (HF)…
- Trial name
- VW-SP-1 (NCT01965015)
- Testing
- Implantation of the V-Wave inter-atrial shunt
- Where
- 6 sites in Germany, Israel and 1 more
- Volunteers
- 16 people
- Sponsor
- V-Wave Ltd
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
Advanced Heart Failure, Heart Transplantation
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy…
- Conditions
- Advanced Heart Failure, Heart Transplantation, Acquired Heart Disease
- Trial name
- TORCH-002 (NCT07836803)
- Testing
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
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
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
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, Congestive, Heart Decompensation
Longitudinal Registry for Advanced Heart Failure Patients
The purpose of this study is to gather information to better understand the characteristics, medical management techniques and outcomes of patients with chronic severe Heart Failure (HF).
- Trial name
- NCT00364416
- Testing
- Any treatment used to treat CHF
- Volunteers
- 1,466 people
- Sponsor
- Scios, Inc.
Heart Failure, Cardiovascular Disease
HeartMate 3™ LIS Study
The purpose of this study is to evaluate a less invasive implantation technique of the HeartMate 3 Left Ventricular Assist System (HM 3 LVAS) in 10 patients.
- Trial name
- HM 3 LIS (NCT02475460)
- Testing
- Less Invasive Surgery (LIS), HeartMate 3™
- Where
- 3 sites in Czechia, Germany
- Volunteers
- 13 people
- Sponsor
- Abbott Medical Devices
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 Pivotal Cohort Extended Follow-up PAS
The study will be a prospective, multi-center, non-blinded, controlled study, intended to evaluate the extended use of the HM3 LVAS compared to the HMII LVAS in those patients that are ongoing at the 2-year follow-up in the…
- Trial name
- NCT03982979
- Testing
- HM3 LVAS
- Where
- United States
- Volunteers
- 295 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
Advanced Heart Failure
First in Human Study of the Icoms Flowmaker
The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump…
- Trial name
- FAIR (NCT07632586)
- Testing
- Cardiac assist device implantation during surgical intervention
- Where
- 2 sites in Czechia, France
- Volunteers
- 10 people
- Sponsor
- FineHeart
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
This study will evaluate the V-Wave Ventura Interatrial shunt. The Shunt is a small, hourglass-shaped device implanted in the dividing wall (septum) between the right and left atria (top chambers) of the heart placed during a…
- Conditions
- Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic, Heart Failure New York Heart Association Class III, Heart Failure Congestive
- Trial name
- RELIEVE-HFrEF (NCT07696975)
- Testing
- Implantation of the V-Wave Interatrial shunt
- Volunteers
- 250 people
- Sponsor
- V-Wave Ltd
Advanced Refractory Left Ventricular Heart Failure
Implantation of the HeartMate 3 in Subjects With Heart Failure Using Surgical SWIFT HM3 PMS
This is a prospective, post-market, multi-center, non-blinded, single arm study of the HeartMate 3 Left Ventricular Assist System (LVAS).
- Trial name
- SWIFT (NCT04548128)
- Testing
- HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
- Where
- 32 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Abbott Medical Devices
Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy
A Study of Genetically Targeted Enzyme Replacement Therapy for Advanced Heart Failure
The purpose of this trial is to assess whether MYDICAR can reduce the frequency and/or delay heart failure related hospitalizations in persons with advanced heart failure when added to their maximal and optimized therapy.
- Conditions
- Ischemic Cardiomyopathy, Non-ischemic Cardiomyopathy, Heart Failure, Cardiomyopathies
- Trial name
- CUPID-2b (NCT01643330)
- Testing
- AAV1/SERCA2a (MYDICAR)
- Where
- 54 sites in United States, Belgium and 8 more
- Volunteers
- 250 people
- Sponsor
- Celladon Corporation
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.
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.