Mapping heart rhythms in patients with atrial fibrillation before their first procedure
Observational Study of Sinus Rhythm Mapping in Pulmonary Vein Isolation Naive Patients With Atrial Fibrillation
This study is testing a new AI tool that looks at heart scans to see if it can help predict problems for people with atrial fibrillation before they have their first heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ziekenhuis Oost-Limburg Academic / other |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06098664 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of an artificial intelligence-enabled ECG algorithm in predicting electropathology in patients with atrial fibrillation (AF) who are undergoing their first pulmonary vein isolation (PVI) procedure. The study focuses on patients who have a 12-lead ECG available in sinus rhythm within the last 14 days. By analyzing the electrical properties of the heart, the researchers hope to identify potential complications and improve treatment outcomes for AF patients. The study will utilize advanced deep neural network technology to assess the data collected from the ECG.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are experiencing their first PVI procedure for atrial fibrillation.
Not a fit: Patients with severe mitral insufficiency or those participating in other conflicting studies may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could enhance the ability to predict complications in atrial fibrillation patients undergoing PVI, leading to better treatment strategies.
How similar studies have performed: While the use of AI in ECG analysis is a growing field, this specific approach to predicting electropathology in AF patients is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provide signed and dated informed consent. * First PVI-procedure * Age is 18 years or higher. * 12-lead ECG available in SR during the last 14 days. Exclusion Criteria: * Mitral insufficiency of grade 3 or 4. * Participating in another study that may interfere with participation in this study
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Recruiting)
Study contacts
- Study coordinator: Henri M.P.B.C. Gruwez, MD
- Email: henri.gruwez@zol.be
- Phone: +3289212051
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.