Clin2
NCT04396899Possibly a fitRecruiting

Stem cell heart patch for advanced heart failure

Heart Failure

Part of Heart & circulation clinical trials.

This early-phase study tests a lab-made heart tissue (“engineered myocardium”) placed surgically to help the heart work better in people with advanced heart failure. It mainly checks safety first, and also looks for signs the patch can improve heart function in selected patients.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 1/Phase 2
Enrollment
53 people
Ages
18 years to 80 years
Study type
Interventional

Who can take part

  • You have symptomatic heart failure despite treatment, with weak heart pumping (left ventricular ejection fraction 35% or less) and symptoms ranging from mild-to-severe (NYHA II to IV).
  • You are already on standard heart failure medications (“guideline-directed medical therapy”) and you’ve had a heart failure hospitalization within the last 12 months.
  • Your blood test shows high heart strain: NT-proBNP above 300 if you’re in normal rhythm, or above 900 if you have atrial fibrillation.
  • Your heart’s ultrasound shows a target area for the transplant (at least one area that moves too little/too much, or a dilated heart chamber).
  • You must be able to undergo the planned surgery type: a left-side minimally invasive approach for certain cases or an open-chest approach for other cases, usually alongside a medically needed heart operation; doctors also look for a specific right-heart function measure (TAPSE under 16 mm).
  • You must be age 18–80 and able/willing to sign consent; if you could become pregnant, you must use reliable birth control during the study.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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