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 not dependent on intravenous inotrope.
Official registry: https://clinicaltrials.gov/study/NCT06526195 · Abbott Medical Devices · enrollment listed as 850
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, or Guideline Medical Directed Therapy. The registry lists allocation as randomized. 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 not dependent on intravenous inotrope.
They plan to enroll about 850 people at 70 sites. Taking part typically means using or being fitted with a device plus check-ins.
Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
Interventions: CardioMEMS HF System, HeartMate 3 Left Ventricular Assist System, Guideline Medical Directed Therapy
Primary outcome (registry wording): Survival at 2 years free of disabling stroke, reoperation to replace the device, or worsening HF requiring listing for urgent heart transplantation or mechanical circulatory support, enrollment into hospice, or dependence on IV inotropes
Nourdine Chakouri, PhD
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 11 sites outside the US on the same record
This study is not a treatment protocol and no experimental treatments are involved. Study participants may be seen as needed for clinical, translational and basic research studies, or as medically indicated.
NCT00081523 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)
Background: \- High blood pressure in the lungs, known as pulmonary arterial hypertension (PAH), is a rare disorder. Some people have disease-associated PAH and some have PAH from an unknown cause.
NCT01730092 · Official ClinicalTrials.gov record · National Institutes of Health Clinical Center (CC)
Background: \- Noncirrhotic Portal Hypertension (NCPH) is caused by liver diseases that increase pressure in the blood vessels of the liver. It seems to start slowly and not have many warning signs.
NCT02417740 · Official ClinicalTrials.gov record · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary