Transplanting heart tissue to aid recovery after heart surgery
Autologous Atrial Appendage Micrografts Transplanted During Coronary Artery Bypass Surgery: the AAMS2 Randomized, Double-blinded, and Placebo-controlled Trial
This study is testing if using small pieces of heart tissue from patients' own hearts during surgery can help them heal better and improve heart function after dealing with heart disease and heart failure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hospital District of Helsinki and Uusimaa Academic / other |
| Locations | 1 site (Helsinki, Uusimaa) |
| Trial ID | NCT05632432 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of atrial appendage micrografts harvested from patients' own heart tissue during coronary artery bypass surgery. The trial aims to assess the effectiveness of these micrografts in promoting cardiac healing and improving heart function in patients suffering from ischemic heart disease and heart failure. Participants will undergo a randomized controlled and double-blinded approach to evaluate the outcomes of this innovative treatment. The study will also involve various assessments, including echocardiography and cardiac MRI, to monitor heart function and tissue response.
Who should consider this trial
Good fit: Ideal candidates are patients with ischemic heart disease and heart failure symptoms classified as NYHA Class II-IV, with a left ventricular ejection fraction between 15% and 40%.
Not a fit: Patients with heart failure due to left ventricular outflow tract obstruction or those who have had an acute myocardial infarction within the last 30 days may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance heart repair and improve quality of life for patients with ischemic heart disease and heart failure.
How similar studies have performed: While the use of autologous tissue for cardiac repair is a promising area, this specific approach of using atrial appendage micrografts is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Helsinki, Uusimaa
- Hospital District of Helsinki and Uusimaa, Helsinki University Hospital, Heart and Lung Center & Cardiac Unit — Helsinki, Uusimaa, Finland (Recruiting)
Study contacts
- Principal investigator: Antti Nykänen, Docent — Hospital District of Helsinki and Uusimaa
- Study coordinator: Antti Nykänen, Docent
- Email: antti.nykanen@hus.fi
- Phone: 050 427 0625
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.