Atrial Appendage Micrograft Transplants to Assist Heart Repair After Cardiac Surgery

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 1, 2024

Primary Completion Date

January 31, 2026

Study Completion Date

December 31, 2026

Conditions
Ischemic Heart DiseaseIschemic CardiomyopathyHeart Failure, SystolicHeart Failure NYHA Class IIIHeart Failure NYHA Class IIHeart Failure NYHA Class IVCoronary Artery Disease
Interventions
PROCEDURE

Epicardial AAMs-patch transplantation

Perioperative assembly of an AAMs-patch with epicardial transplantation onto the epicardium of the scarred myocardium at the end of CABG surgery

DIAGNOSTIC_TEST

RNA-stabilized whole blood sampling

Collection (preoperative and at 6-month-follow-up) of TEMPUS(TM) stabilizing whole blood for epitranscriptomics-oriented measurements

DIAGNOSTIC_TEST

Plasma sampling

Collection (preoperative and at 6-month follow-up) of blood-derived both RNA-stabilized and non-stabilized plasma aliquots for epitranscriptomic-oriented and other CVD biomarker oriented measurements, respectively

DIAGNOSTIC_TEST

Transthoracic echocardiography

To assess cardiac structure and function both pre- and postoperatively (at both hospital discharge and 3-month follow-up)

DIAGNOSTIC_TEST

Late-gadolinium enhancement cardiac magnetic resonance imaging (LGE-CMRI)

To assess detailed cardiac structure (i.e. interstitial fibrosis) and function both preoperatively and at 6-month follow-up postoperatively.

OTHER

Symptom-scaling

Standardised evaluation of IHD and HF-related angina pectoris (CCS) and dyspnea (NYHA) and life quality (RAND36) pre- and postoperatively (at both 3- and 6-month follow-up).

OTHER

6-minute walking test (6MWT)

Standardised assessment of physcial capacity pre- and postoperatively (at 6-month follow-up)

DIAGNOSTIC_TEST

Blood sampling (NT-proBNP)

Collection of a blood sample measurement of NT-proBNP by an accredited hospital laboratory pre- and postoperatively (at both 3- and 6-month follow-up).

DIAGNOSTIC_TEST

Transesophageal echocardiography

Performed by the perfusion-anesthesiologist at the beginning of the CABG surgery to evaluate both LAA and RAA for blood flow velocities, anatomy, possible sludge and thrombus.

PROCEDURE

Epicardial collagen-based patch transplantation

Epicardial transplantation of the collaged-based patch material without the AAMs onto the epicardium of the scarred myocardium at the end of CABG surgery.

Trial Locations (1)

00029

RECRUITING

Hospital District of Helsinki and Uusimaa, Helsinki University Hospital, Heart and Lung Center & Cardiac Unit, Helsinki

All Listed Sponsors
collaborator

University of Helsinki

OTHER

collaborator

Oulu University Hospital

OTHER

lead

Hospital District of Helsinki and Uusimaa

OTHER