Tissue, Blood and Biomarkers to Predict Future Atrial Fibrillation (PREDICT-AF)

PREventive Left Atrial appenDage Resection for predICtion of fuTure Atrial Fibrillation

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation

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.

• Study Type: Observational
• Enrollment (Actual): 150

Contacts and Locations

Study Locations

• Netherlands
  • North-Holland
    • Amsterdam, North-Holland, Netherlands, 1105AZ
      • Academic Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac surgery patients; The study cohort will comprise of patients without a history of AF that undergo cardiac surgery (CABG or mitral valve surgery) with increased CHADSVASC scores of ≥2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incident Atrial Fibrillation	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).	within 2 years after surgery
Postoperative Atrial Fibrillation	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.	within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life defined by 36-Item Short Form Health Survey questionnaire	The quality of life is measured by 36-Item Short Form Health Survey questionnaires.	at 6 months and 1 year follow-up

Collaborators and Investigators

• Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Investigators: Principal Investigator: Joris de Groot, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2015
• Primary Completion (Actual): July 6, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: November 9, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: biomarker; microRNA
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: NL50754.018.14