Comparing two methods for treating left atrial flutter
Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial
NA · Hospital Universitario La Paz · NCT05063032
This study is testing which of two different heart procedures works better to stop left atrial flutter from coming back in patients who have it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario La Paz (other) |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05063032 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a unicenter, randomized, open-label study that compares two techniques for ablation of left atrial flutter: high-density mapping and strict linear ablation. Patients with inducible left atrial flutter will be randomly assigned to one of the two intervention groups. The primary outcome is the recurrence of arrhythmias over a one-year follow-up period, monitored through daily ECG samples. The study aims to determine which method is more effective in preventing arrhythmia recurrences.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with inducible left atrial flutter who have clinical indications for ablation.
Not a fit: Patients who have previously undergone ablation for left atrial flutter or have complex congenital heart disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with left atrial flutter, potentially reducing the recurrence of arrhythmias.
How similar studies have performed: Other studies have shown promising results with high-density mapping techniques in arrhythmia management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * Left atrial flutter1 inducible during electrophysiological evaluation. * Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug. * Informed consent. 1. Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above. Exclusion criteria * Previous ablation of LAFL. * Previous linear ablation in the LA except for pulmonary vein isolation. * Absolute contraindication for oral anticoagulation. * Stroke or acute coronary syndrome less than 3 months before ablation. * Complex congenital heart disease.
Where this trial is running
Madrid
- La Paz University Hospital, Department of Cardiology — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Sergio C Castrejón, PhD
- Email: lapaz@arritmias.net
- Phone: +34 659048245
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.
Conditions: Arrhythmias, Cardiac, Left atrial flutter, Linear ablation, High-density mapping