Transplanting heart tissue to aid recovery after heart surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.