Mapping the left atrium to evaluate heart surgery ablation lesions
Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions for Treatment of Atrial Fibrillation
This study is testing if re-mapping the heart three months after surgery can help doctors see how well the initial treatment for atrial fibrillation worked and if more treatment is needed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Medical Centre Ljubljana Academic / other |
| Locations | 1 site (Ljubljana) |
| Trial ID | NCT05714800 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients undergoing heart surgery who also require concomitant ablation for atrial fibrillation. It aims to perform invasive re-mapping of the left atrium three months post-ablation to assess the durability of the ablation lesions and identify any conduction gaps that may lead to arrhythmia recurrence. Using a high-density mapping catheter and a three-dimensional electro-anatomical mapping system, the study will evaluate the effectiveness of the initial ablation and determine if additional ablation is necessary. Participants will be monitored clinically and with Holter ECG for up to one year following the procedure.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for elective heart surgery who also have an indication for concomitant ablation for atrial fibrillation.
Not a fit: Patients with a life expectancy of less than one year or severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved long-term outcomes for patients with atrial fibrillation undergoing heart surgery by reducing the recurrence of arrhythmias.
How similar studies have performed: Other studies have shown promise in similar approaches to mapping and ablation, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * all patients scheduled for any kind of elective heart surgery having also indication (EHRA and/or HRS guidelines) to undergo concomitant ablation for any type of atrial fibrillation Exclusion Criteria: * life expectancy of less than one year, * severe heart failure with left ventricular ejection fraction below 35%, * emergency surgery due to a life threatening condition such as acute aortic dissection, papillary muscle rupture, acute endocarditis, major trauma,...
Where this trial is running
Ljubljana
- University Medical Centre Ljubljana — Ljubljana, Slovenia (Recruiting)
Study contacts
- Study coordinator: Matevž Jan, MD
- Email: matevz.jan@kclj.si
- Phone: 0038615228238
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.