Clinical trial NCT03130985: Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation
Official title: PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: microRNA
biomarker
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients are eligible that are referred to the investigators' tertiary cardiothoracic center for mitral valve surgery, (aortic) valve surgery or coronary artery bypass surgery and meet in- and exclusion criteria.

Brief summary: Patients undergoing coronary artery bypass grafting (CABG), aortic (valve) or mitral valve surgery are at risk of developing postoperative and new-onset atrial fibrillation (AF), but adequate risk prediction is currently impossible. This study aims to discover tissue and circulating microRNAs and protein biomarkers that may help to unravel the pathophysiological processes underlying AF and are potential tools for risk stratification and prognosis or may become future targets of therapy.

This study will be a single-center cohort study of 150 patients undergoing cardiac surgery, which will constitute the beginning of the follow-up period. Left atrial appendages, whole blood and epicardial mappings will be collected. Patients will be followed for 2 years with regular holter investigations to detect postoperative and new-onset AF.

Detailed description: Study procedures:

The left atrial appendage (LAA) will be removed for research and intended prophylactic purposes, using a surgical stapler or surgical knife prior to the standard procedure. Epicardial mappings may be performed during cardiac surgery with a 48-multi-electrode. Patients will be followed with regular 24-hour Holter investigations.

This study will be an exploratory study with a required inclusion of 150 patients, based on the estimated event rate. Patients will be recruited by the investigators during pre-operative assessment.

Clinical data will be gathered at baseline and stored in a customized microsoft access entry database. Statistical analysis will be performed in collaboration with the Bioinformatics Laboratory from the Academic Medical Center.

Eligibility criteria: Inclusion Criteria:

* Elective sternotomy for either coronary artery bypass surgery or aortic (valve) surgery or mitral valve surgery
* CHA2DS2 VASC score ≥ 2
* Sinus rhythm
* Age between 18 and 80 years
* Legally competent and willing and able to sign informed consent

Exclusion Criteria:

* Unable or unwilling to comply with study procedures
* Documented or reported history of atrial fibrillation, atrial flutter (duration \> 5 minutes) or ventricular tachycardia
* Emergency or redo of CABG
* Emergency valvular surgery or pericarditis or endocarditis
* NYHA class IV heart failure symptoms or left ventricular ejection fraction \< 35%
* Pregnancy or of childbearing potential without adequate contraception
* History of previous radiation therapy of the thorax
* Active malignancy
* Active inflammtion or auto-immune disease
* Surgery for congenital anomalies
* Circumstances that prevent follow-up (no permanent home or address, transient, etc.)

Primary outcomes:
measure: incident Atrial Fibrillation
timeFrame: within 2 years after surgery
measure: Postoperative Atrial Fibrillation
timeFrame: within the first 30 days after surgery
Secondary outcomes:
measure: Quality of Life defined by 36-Item Short Form Health Survey questionnaire
timeFrame: at 6 months and 1 year follow-up
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
state: North-Holland
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Joris de Groot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Berg NWE, Neefs J, Kawasaki M, Nariswari FA, Wesselink R, Fabrizi B, Jongejan A, Klaver MN, Havenaar H, Hulsman EL, Wintgens LIS, Baalman SWE, Meulendijks ER, van Boven WJ, de Jong JSSG, van Putte BP, Driessen AHG, Boersma LVA, de Groot JR; PREDICT-AF Investigators. Extracellular matrix remodeling precedes atrial fibrillation: Results of the PREDICT-AF trial. Heart Rhythm. 2021 Dec;18(12):2115-2125. doi: 10.1016/j.hrthm.2021.07.059. Epub 2021 Jul 29.
citation: van den Berg NWE, Neefs J, Berger WR, Boersma LVA, van Boven WJ, van Putte BP, Kaya A, Kawasaki M, Driessen AHG, de Groot JR; PREDICT AF Investigators. PREventive left atrial appenDage resection for the predICtion of fuTure atrial fibrillation: design of the PREDICT AF study. J Cardiovasc Med (Hagerstown). 2019 Nov;20(11):752-761. doi: 10.2459/JCM.0000000000000868.