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

NCT03962166 · tracked via the Priya Life Science Denmark tracker

Sponsor

Helena DOMINGUEZ

Phase

Observational

Started

2019-10-07

Last updated

2026-01-16

Condition(s) studied

Atrial FibrillationLeft Ventricular Diastolic Dysfunction

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Age \>18 years * First time open-heart surgery * Coronary artery bypass grafting and/or valve surgery * Signed informed consent Exclusion Criteria: * 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

Primary outcome measure(s)

Atrial fibrillation — before discharge within two weeks after surgery
Occurence/recurrence of atrial fibrillation

Trial sites (1)

Facility	City	Region	Status
Cardiology department Y, Bispebjerg-Frederiksberg Hospital	Frederiksberg	Denmark

More Helena DOMINGUEZ trials in Denmark

Left Atrial Appendage Closure by Surgery-2 Active, not recruiting

Other trials for the same condition

The Cardio-share Telemedicine Cross-sector Collaboration Model for Managing Vulnerable Patients With Heart Failure Recruiting

CHAMPION-AF Clinical Trial Active, not recruiting

Amplatzer Amulet LAAO vs. NOAC Active, not recruiting

Can Patients With Atrial Fibrillation Safely Discontinue Anticoagulant Therapy After Cardiac Surgery? (ATLAAC) Recruiting

SGLT2 Inhibitor TrEatment iN Patients Awaiting cOronary arTery bYpass Surgery to Reduce Post-opErative AF Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03962166 on ClinicalTrials.gov ↗ ← All trials in Denmark