Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure
- Conditions
- Heart Failure
- Registration Number
- NCT02672163
- Lead Sponsor
- Helsinki University Central Hospital
- Brief Summary
This study aims to evaluate the safety and clinical feasibility of epicardially delivered autologous atrial appendage micrografts in the treatment of heart failure. The micrografts consisting atrial-derived cells and their extracellular matrix, are placed on an infarction scar during CABG surgery.
- Detailed Description
The atrial appendages are a tissue reservoir for cardiomyocyte stem and precursor cells. During coronary artery bypass graft (CABG) surgery part of the right atrial appendage can be excised upon insertion of the right atrial cannula of the heart-lung machine. This study aims to address the surgical feasibility and patient safety of epicardially delivered atrial appendage micrografts during CABG surgery.
Autologous cardiac cells are harvested from right atrial appendage during CABG of six patients. Micrografts consisting atrial appendage-derived cells (AADCs) and their extracellular matrix (ECM) of the atrial appendage are mechanically processed. The cells are placed on a tissue-engineered sheet with fibrin gel and tissue clue and further delivered epicardially on top of a infarction scar. Parameters including echocardiography reflecting cardiac insufficiency are studied pre- and post-operatively as well as at three and six months of the follow-up. Cardiac functional magnetic resonance imaging is performed preoperatively and at six-months follow-up. 20 patients will be recruited to serve as a control group. They are scheduled for elective CABG and are treated according to the normal hospital protocol, without the ECM sheet.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
- Informed consent obtained
- Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
- New York Heart Association (NYHA) Class II-IV heart failure symptoms
- Heart failure due to left ventricular outflow tract obstruction
- 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 <84 ml/min/1.73m)
- Other disease limiting life expectancy
- Contraindications for coronary angiogram or MRI
- Participation in some other clinical trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety; need for vasoactive medication 6 months For assessing haemodynamics during the operation and at the intensive care unit
Safety; cardiac index in l/min/m 6 months For assessing haemodynamics during the operation and at the intensive care unit
Safety; hemoglobin in g/l 6 months For assessing haemodynamics during the operation and at the intensive care unit
Safety; oxygen saturation in the pulmonary arterial blood (SvO2) in % 6 months For assessing haemodynamics during the operation and at the intensive care unit
Safety; serum potassium level in mmol/l 6 months For assessing haemodynamics during the operation and at the intensive care unit
Safety; blood glucose level in mmol/l 6 months For assessing haemodynamics during the operation and at the intensive care unit
Safety; Left ventricular ejection fraction (EF) in % 6 months For assessing cardiac function during and after the operation by echocardiogram
Safety; pericardial effusion in mm 6 months For assessing cardiac function after the operation by echocardiogram
Safety: telemetric monitoring of rhythm 6 months For assessing cardiac function after the operation
Feasibility: Success in completing the delivery of the cell sheet to the myocardium 6 months Measured in 0= success, 1= no success
Feasibility: Waiting time in minutes for the cell sheet 6 months Waiting time in minutes for the finished cell sheet to be placed on the myocardium after doing all the required anastomoses
Feasibility: Waiting time in minutes for the heart 6 months Waiting time in minutes for the the heart after doing all the anastomoses and before the cell sheet is finished
Feasibility: Closing the right atrial appendage 6 months Closing the right atrial appendage after removing the standardized tissue piece for preparing the cell sheet. According to the hospital protocol, appendage is closed with purse string suture. 0 = no additional suturing needed, 1 = additional suturing needed.
- Secondary Outcome Measures
Name Time Method Left ventricular wall thickness 6 months Measured by MRI
Change in the amount of myocardial scar tissue 6 months Measured by MRI
Change in left ventricular ejection fraction 6 months Measured by MRI
Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels 6 months New York Heart Association class 6 months Changes in the quality of life. 6 months measured by questionnaire
Local changes in systolic and diastolic function 3 months Measured by echocardiogram
Change in movement and diastolic function of left ventricular wall 6 months Measured by MRI
Days in hospital 1 month
Trial Locations
- Locations (1)
Annu Nummi
🇫🇮Helsinki, Finland
Annu Nummi🇫🇮Helsinki, Finland