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Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery

RecruitingNAAges 18 Years - 75 YearsAllHospital District of Helsinki and Uusimaa
NCT05632432 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Ischemic heart disease (IHD) leads the global mortality statistics. Atherosclerotic plaques in coronary arteries hallmark IHD, drive hypoxia, and may rupture to result in myocardial infarction (MI) and death of contractile cardiac muscle, which is eventually replaced by a scar. Depending on the extent of the damage, dysbalanced cardiac workload often leads to emergence of heart failure (HF). The atrial appendages, enriched with active endocrine and paracrine cardiac cells, has been characterized to contain cells promising in stimulating cardiac regenerative healing. In this AAMS2 randomized controlled and double-blinded trial, the patient's own tissue from the right atrial appendage (RAA) is for therapy. A piece from the RAA can be safely harvested upon the set-up of the heart and lung machine at the beginning of coronary artery bypass (CABG) surgery. In the AAMS2 trial, a piece of the

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📋 Eligibility rules (as published)
Inclusion Criteria: * Informed consent obtained * Left ventricular ejection fraction (LVEF) between ≥ 15% and ≤ 40% at recruitment (transthoracic echocardiography) * New York Heart Association (NYHA) Class II-IV heart failure symptoms Exclusion Criteria: * Heart failure due to left ventricular outflow tract obstruction * Acute myocardial infarction (AMI) within last 30 days * History of life-threatening and possibly repeating ventricular arrhythmias or resuscitation, or an implantable cardioverter-defibrillator * Stroke or other disabling condition within 3 months before screening * Severe valve disease or scheduled valve surgery * Renal dysfunction (GFR \<45 ml/min/1.73m2) * Other disease limiting life expectancy * Contraindications for coronary angiogram or LGE-CMRI * Participation in some other clinical trial Screening Failure: * After optimization of medications, no visible scar or LVEF ≥ 50% in preoperative LGE-CMRI * Preoperative LGE-CMRI has not been performed prior scheduled CABG
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What it tests

  • Epicardial AAMs-patch transplantation
  • RNA-stabilized whole blood sampling
  • Plasma sampling
  • Transthoracic echocardiography
  • Late-gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI)
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Where

1 site
Hospital District of Helsinki and Uusimaa, Helsinki University Hospital, Heart and Lung Center & Cardiac Unit
Helsinki, Finland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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