Trial to Evaluate Safety And Effectiveness of Mechanical Circulatory Support in Patients With Advancing Heart Failure (NCT06526195)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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:
8. Subject has been implanted with a CardioMEMS PA Sensor for at least 90 days.
9. 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 Receptor Blockers or angiotensin receptor neprilysin inhibitor (if eligible), Mineralocorticoid Receptor Antagonists, Sodium-Glucose co-Transporter-2 (SGLT2) inhibitors, and diuretics for at least 30 of the last 90 days.
10. mean PAP ≥ 30 mmHg.
11. The subject will not be randomized if they have any other factor that represents inordinate risk for either continued GDMT or LVAD implant. Single Arm Registry Criteria:
12. Subject has received a CardioMEMS PA Sensor implant following enrollment in the trial.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (68 Sites)

• Banner-University Medical Center Phoenix — Phoenix, Arizona
• Baptist Health Medical Center — Little Rock, Arkansas
• Sutter Medical Center — Sacramento, California
• University of California at San Francisco — San Francisco, California
• Washington Hospital Center — Washington D.C., District of Columbia
• Shands at the University of Florida — Gainesville, Florida
• Cleveland Clinic Florida — Weston, Florida
• Piedmont Heart Institute — Atlanta, Georgia
• Piedmont Augusta Hospital — Augusta, Georgia
• WellStar Kennestone Hospital — Marietta, Georgia
• University of Chicago — Chicago, Illinois
• Advocate Health & Hospitals Corporation — Oakbrook Terrace, Illinois
• St. Vincent Hospital — Indianapolis, Indiana
• University of Iowa Hospitals & Clinics — Iowa City, Iowa
• Kansas University Medical Center — Kansas City, Kansas
• University of Kentucky — Lexington, Kentucky
• Norton Hospital — Louisville, Kentucky
• Maine Medical Center — Portland, Maine
• Massachusetts General Hospital — Boston, Massachusetts
• Henry Ford Hospital — Detroit, Michigan
• Spectrum Health Butterworth Hospital — Grand Rapids, Michigan
• Minneapolis Heart Institute — Minneapolis, Minnesota
• Mayo Clinic — Rochester, Minnesota
• St. Luke's Hospital — Kansas City, Missouri
• University of Nebraska Medical Center — Omaha, Nebraska

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.