Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery

Launched by HOSPITAL DISTRICT OF HELSINKI AND UUSIMAA · Nov 18, 2022

Keywords

ClinConnect Summary

This clinical trial, called AAMS2, is studying a new way to help people with heart problems recover after cardiac surgery. It focuses on using a small piece of tissue from the patient's own heart, specifically from the right atrial appendage, to promote healing and improve heart function. Patients with ischemic heart disease, heart failure, or related conditions may be eligible to participate, provided they have a specific level of heart function and certain symptoms.

During the trial, participants will undergo coronary artery bypass surgery, where a piece of their heart tissue will be processed and placed back on their heart to aid recovery. The study will compare the effects of this treatment to a standard patch without the special heart tissue. Participants can expect to have follow-up assessments, including blood tests and heart imaging, at six months after their surgery to see how well their heart is healing. This study aims to determine not only if this method is safe but also if it can help reduce heart damage and improve overall heart health.

Gender

ALL

Eligibility criteria

• 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