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Autologous Atrial Appendage Derived Cells in the Treatment of Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672163
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : March 5, 2020
Sponsor:
Information provided by (Responsible Party):
Ari Harjula, 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.

Condition or disease Intervention/treatment Phase
Heart Failure Procedure: CABG surgery Procedure: AADC therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Epicardial Delivery of Autologous Atrial Appendage Micrografts During Coronary Artery Bypass Surgery - Safety and Feasibility Study
Study Start Date : February 2016
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: AACD-Therapy group
6 patients are recruited to the AADC-therapy group. Autologous atrial appendage derived cells (AADCs) are harvested from the appendage tissue removed during the venal cannulation of bypass. The cells and their extracellular matrix are placed with tissue clue to Cormatrix-sheet and further on top of the myocardium in the area of infarction scar. The procedure is done simultaneously with CABG surgery. The patients will be carefully monitored after the operations and cardiac MRI and echocardiogram will be performed previously to surgery as well as during the follow ups.
Procedure: CABG surgery
Elective CABG surgery

Procedure: AADC therapy
Atrial appendage derived cells are placed on the site of a infarct scar with matrix sheet

Active Comparator: Control group
20 patients are recruited to form the control group. They are patients scheduled for elective CABG surgery and they meet the same inclusion and exclusion criteria as the therapy group. There patients are followed as the hospital protocol with out any additional imagination or blood tests.
Procedure: CABG surgery
Elective CABG surgery




Primary Outcome Measures :
  1. Safety; need for vasoactive medication [ Time Frame: 6 months ]
    For assessing haemodynamics during the operation and at the intensive care unit

  2. Safety; cardiac index in l/min/m [ Time Frame: 6 months ]
    For assessing haemodynamics during the operation and at the intensive care unit

  3. Safety; hemoglobin in g/l [ Time Frame: 6 months ]
    For assessing haemodynamics during the operation and at the intensive care unit

  4. Safety; oxygen saturation in the pulmonary arterial blood (SvO2) in % [ Time Frame: 6 months ]
    For assessing haemodynamics during the operation and at the intensive care unit

  5. Safety; serum potassium level in mmol/l [ Time Frame: 6 months ]
    For assessing haemodynamics during the operation and at the intensive care unit

  6. Safety; blood glucose level in mmol/l [ Time Frame: 6 months ]
    For assessing haemodynamics during the operation and at the intensive care unit

  7. Safety; Left ventricular ejection fraction (EF) in % [ Time Frame: 6 months ]
    For assessing cardiac function during and after the operation by echocardiogram

  8. Safety; pericardial effusion in mm [ Time Frame: 6 months ]
    For assessing cardiac function after the operation by echocardiogram

  9. Safety: telemetric monitoring of rhythm [ Time Frame: 6 months ]
    For assessing cardiac function after the operation

  10. Feasibility: Success in completing the delivery of the cell sheet to the myocardium [ Time Frame: 6 months ]
    Measured in 0= success, 1= no success

  11. Feasibility: Waiting time in minutes for the cell sheet [ Time Frame: 6 months ]
    Waiting time in minutes for the finished cell sheet to be placed on the myocardium after doing all the required anastomoses

  12. Feasibility: Waiting time in minutes for the heart [ Time Frame: 6 months ]
    Waiting time in minutes for the the heart after doing all the anastomoses and before the cell sheet is finished

  13. Feasibility: Closing the right atrial appendage [ Time Frame: 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 :
  1. Left ventricular wall thickness [ Time Frame: 6 months ]
    Measured by MRI

  2. Change in the amount of myocardial scar tissue [ Time Frame: 6 months ]
    Measured by MRI

  3. Change in left ventricular ejection fraction [ Time Frame: 6 months ]
    Measured by MRI

  4. Plasma concentrations of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels [ Time Frame: 6 months ]
  5. New York Heart Association class [ Time Frame: 6 months ]
  6. Days in hospital [ Time Frame: 1 month ]
  7. Changes in the quality of life. [ Time Frame: 6 months ]
    measured by questionnaire

  8. Change in movement and diastolic function of left ventricular wall [ Time Frame: 6 months ]
    Measured by MRI

  9. Local changes in systolic and diastolic function [ Time Frame: 3 months ]
    Measured by echocardiogram



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained
  • Left ventricular ejection fraction (LVEF) between ≤50% and ≥15%
  • New York Heart Association (NYHA) Class II-IV heart failure symptoms

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672163


Locations
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Finland
Annu Nummi
Helsinki, Finland, 00029
Sponsors and Collaborators
Helsinki University Central Hospital
Investigators
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Study Director: Ari Harjula, Prof Heart and Lung Center, Helsinki University Hospital
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ari Harjula, Professor, Clinical research, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT02672163    
Other Study ID Numbers: 180/13/03/02/2013
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: March 5, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ari Harjula, Helsinki University Central Hospital:
autologous micrografts
heart failure
coronary artery bypass surgery
cell therapy
atrial appendage
epicardial cell delivery
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases