Characterizing Patients With POAF in Relation to Cardiac Surgery by wavECG and TTE

NCT03962166 | Active Not Recruiting

• 1 other identifier: H-17033253-S1
• Study Type: observational
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

Post-operative atrial fibrillation (POAF) is frequently observed after open-heart surgery. Despite numerous attempts to predict POAF, it remains a challenge to correctly identify the patients at risk. New technologies are available but not yet in cooperated in clinical guidelines and prediction models. We aim at identifying patients at risk of AF occurrence/recurrence after open-heart surgery by use of signal processed surface ECG (wavECG). The study is an explorative, prospective cohort study of 100 patients undergoing first-time elective open-heart surgery in the Left Atrial Appendage Closure by Surgery-2 (LAACS-2) trial (NCT03724318). Patients are examined by electrocardiogram (ECG), wavECG, transthoracic echocardiography and continuous heart rhythm monitoring. Primary endpoint is occurrence/recurrence of AF. Left ventricular diastolic dysfunction as evaluated by wavECG will be used to predict incidence of primary endpoint.

Conditions

Atrial Fibrillation; Left Ventricular Diastolic Dysfunction

Keywords

atrial fibrillation; left ventricular diastolic dysfunction; electrocardiogram; signal processed surface ECG; wavECG; transthoracic echocardiography

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  Occurence/recurrence of atrial fibrillation

  before discharge within two weeks after surgery

Other Outcomes (2)

• Left atrial dysfunction

  Two years post surgery

• Left ventricular diastolic dysfunction

  Two years post surgery

Study Arms (1)

Cohort

consecutive adult patients undergoing first-time elective open-heart surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive adult patients undergoing first-time elective open-heart surgery at Department of Cardiothoracic Surgery at Copenhagen University Hospital not fulfilling any exclusion criteria and who have signed informed consent

You may qualify if:

• Age \>18 years
• First time open-heart surgery
• Coronary artery bypass grafting and/or valve surgery
• Signed informed consent

You may not qualify if:

• Planned closure of the left atrial appendage
• Planned ablation for atrial fibrillation during surgery
• Ongoing inflammation or infection (including endocarditis)
• Connective tissue disease
• Ongoing cancer (not control)
• Pregnancy
• Follow-up not possible

Sponsors & Collaborators

• Helena DOMINGUEZ: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Cardiology department Y, Bispebjerg-Frederiksberg Hospital

Frederiksberg, 2000, Denmark

Location

Related Publications (40)

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MeSH Terms

Conditions

Atrial Fibrillation; Ventricular Dysfunction, Left

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ventricular Dysfunction

Study Officials

• Helena Dominguez

  University Hospital Bispebjerg and Frederiksberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, associate professor

Study Record Dates

• First Submitted: May 1, 2019
• First Posted: May 23, 2019
• Study Start: October 7, 2019
• Primary Completion: December 30, 2023
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

DK (1)