Academic Medical Center
Amsterdam, North Holland, 1105AZ, Netherlands
NCT Number: NCT03130985
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.
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Notify Me18 year–80 year
All sexes
Observational
Amsterdam, North Holland, 1105AZ, Netherlands
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: within 2 years after surgery
A de novo 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode within 2 years after surgery (with a blanking period for the postoperative period <30 days).
Time frame: within the first 30 days after surgery
A 30 second continuous rhythm registration of AF, or an ECG recording of an AF episode in the first 30 days following cardiac surgery or registered at the first 24h Holter monitoring if scheduled within 6 weeks following cardiac surgery.
Time frame: at 6 months and 1 year follow-up
The quality of life is measured by 36-Item Short Form Health Survey questionnaires.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Other
PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation
Acronym: PREDICT-AF
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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