NCT06526195 Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure
| NCT ID | NCT06526195 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Abbott Medical Devices |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 850 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2029-09 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subject has provided written informed consent by signing the study Informed Consent Form (ICF) prior to any clinical investigation-related procedure 2. LVEF ≤30% and Cardiac Index ≤ 2.5 L/min/m² 3. Limited functional status as demonstrated by 6MWT ≤ 350 m due to HF related reasons OR peak VO2 ≤ 14 mL/kg/min (or \<50% of predicted peak VO2 value) 4. NYHA Class IIIB or NYHA Class IV 5. Subject has ≥ 1 Heart Failure Hospitalization in the last 12 months 6. Subject is already implanted with a CardioMEMS PA Sensor OR willing to undergo a CardioMEMS PA Sensor implant 7. Subject is willing and able to be implanted with the HM3 LVAS if randomized to HM3 Group Randomization Criteria: 1. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days. 2. Subject is receiving guideline directed medical therapy with optimal doses (or documented medication contraindication or intolerance) of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.