Clinical trials: Advanced Heart Failure
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
Advanced Heart Failure, Left Ventricular Assist Devices
Trial of Low-intensity Anticoagulation to Reduce GI or Other Bleeding Complications With Equivalent Therapeutic Efficacy in HeartMate 3 LVAD Patients
The TARGET trial is a prospective, single-center, randomized, open-label, active-controlled inequality clinical trial designed to evaluate the safety and efficacy of low-intensity anticoagulation therapy (target INR 1.5-2.0)…
- Conditions
- Advanced Heart Failure, Left Ventricular Assist Devices, Anticoagulation Treatment, Bleeding Complications
- Trial name
- TARGET (NCT07081035)
- Testing
- Warfarin (low-intensity anticoagulation), Warfarin (standard anticoagulation)
- Where
- South Korea
- Volunteers
- 94 people
- Sponsor
- Asan Medical Center
Advanced Heart Failure
Wearables and Artificial Intelligence in Advanced Heart Failure Care
The goal of this observational study is to evaluate whether AI-based analyses of wearable sensor data can identify early signs of deterioration leading to hospitalization in patients with advanced heart failure.
- Trial name
- WAI-HF (NCT07051356)
- Where
- Netherlands
- Volunteers
- 200 people
- Sponsor
- UMC Utrecht
Advanced Heart Failure
European Clinical Evaluation of the Carmat Total Artificial Heart
The objective of this clinical investigation is to evaluate the safety and performance of the Carmat Total Artificial Heart (TAH) in subjects with advanced heart failure requiring biventricular support.
- Trial name
- ADVANCEHF (NCT02962973)
- Testing
- CARMAT TAH, Surgical intervention
- Where
- 2 sites in Kazakhstan, Netherlands
- Volunteers
- 20 people
- Sponsor
- Carmat SAS
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
Advanced Heart Failure, Heart Failure With Reduced Ejection Fraction
Screening for Advanced Heart Failure IN Stable outPatientS - The SAINTS Study (SAINTS B)
SAINTS B is a randomized, controlled, clinical trial. Patients identified with advanced heart failure in SAINTS A who are unwilling or unable to undergo heart transplantation or left ventricular assist device implantation will be…
- Trial name
- SAINTS B (NCT05284955)
- Testing
- CardioMEMS HF System, Standard heart failure medical therapy
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- Finn Gustafsson
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
Chronic or Acute Advanced Heart Failure
South Of France Cardiac Assist Registry
Chronic heart failure is a common disease. It is also a serious disease with a mortality of 50% at 5 years, representing a significant cost in terms of public health expenditure.
- Trial name
- SOFCAR (NCT02877446)
- Where
- France
- Volunteers
- 200 people
- Sponsor
- University Hospital, Montpellier
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
Advanced Refractory Left Ventricular Heart Failure
MOMENTUM 3 IDE Clinical Study Protocol
The objective of the study is to evaluate the safety and effectiveness of the HM3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure.
- Trial name
- HM3™ (NCT02224755)
- Testing
- HeartMate 3 LVAS, HeartMate II LVAS
- Where
- 69 sites in United States
- Volunteers
- 1,028 people
- Sponsor
- Abbott Medical Devices
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 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, CRT and/or ICD
Screening for Advanced Heart Failure Treatment (SEE-HF)
Advanced heart failure therapy (heart transplantation or LVAD) is underutilized and patients are underserved. The purpose of this prospective, observational study is to obtain multi-center data on the proportion of patients with…
- Trial name
- SEE-HF (NCT01626404)
- Where
- 7 sites in Denmark, France and 4 more
- Volunteers
- 99 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
Systolic Chronic Heart Failure, Congestion, Venous
Ultrasound-assessed Internal Jugular Vein Distensibility in Advanced Chronic Heart Failure (US-IJVD in CHF)
Prospective validation of the ultrasound-assessed internal jugular vein distensibility (JVD) ratio to identify patients with systolic chronic heart failure and right atrial pressure (RAP) of 7 or less mmHg measured by the right…
- Conditions
- Systolic Chronic Heart Failure, Congestion, Venous, Advanced Heart Failure
- Trial name
- US-IJVD-CHF (NCT03874312)
- Testing
- Linear ultrasound (US) assessment of the internal jugular vein
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Niguarda Hospital
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
Advanced Heart Failure
Advanced Care Management in Patients With Advanced Heart Failure
The purpose of this study is to explore the trajectory of advanced management care in patients with heart failure over a period of 9 months, then comparing the medical treatment accepted by patients after 2 years later and…
- Trial name
- NCT03526627
- Where
- Taiwan
- Volunteers
- 227 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
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
Locally Advanced Cancer, Metastatic Cancer
Identification of In-hospital Patients in Need of Palliative Care Using a New Simplified Screening Tool
Every day many patients affected by chronic life-limiting illnesses are admitted into Internal Medicine wards, coming from the Emergency Department.
- Conditions
- Locally Advanced Cancer, Metastatic Cancer, Chronic Respiratory Failure, Chronic Heart Failure
- Trial name
- SST2017 (NCT04143230)
- Testing
- Screening for PC by means of two different screening tools
- Where
- Italy
- Volunteers
- 660 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Blood Pressure, Heart Failure
Wrist Worn Blood Pressure Measurement
In this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (A-line) blood pressure monitors.
- Conditions
- Blood Pressure, Heart Failure, Advanced Heart Failure, Heart Failure，Congestive
- Trial name
- NCT03919136
- Testing
- Wrist-worn measurement device (LiveMetric)
- Where
- 3 sites in United States
- Volunteers
- 40 people
- Sponsor
- LiveMetric S.A.