Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
SLICE-LAMRT is a multicenter, prospective, randomized, double-blind trial that will be carried out in patients older than 18 years with atypical flutter suspected to be of left atrial origin. The aim of this trial is to evaluate the safety and superiority of a substrate-guided ablation procedure vs the conventional strategy guided by electrical activity.
The composite primary endpoint is time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation.
Left atrial macroreentrant tachycardias (LAMRT), also known as left atrial flutter, represent a small percentage of supraventricular arrhythmiass. These tachycardias occur due to reentrant circuits, that is, electrical activation that occurs around natural anatomical obstacles or scar areas.
Classically, by analogy with ventricular tachycardias, these tachycardias are approached by delimiting the circuit (locating the anatomical and functional obstacles), searching for critical areas for their maintenance (isthmuses, generally of slow conduction) and creating controlled lesions that interrupt these circuits (catheter ablation). This requires electromagnetic mapping systems and uses programmed stimulation techniques. This approach treats flutter(s) present at the time of ablation to prevent recurrence. However, it is not uncommon for these patients to develop new macroreentrant circuits during the subsequent clinical course, so the recurrence rate of atrial arrhythmias in this population is relatively high.
The goal of this trial is to determine whether substrate-guided ablation of atypical atrial flutter is superior to electrical activation-guided ablation in reducing the recurrence of atrial arrhythmias and increasing the time to first recurrence of atrial fibrillation, atrial flutter, or atrial tachycardia. The investigators hypothesize that ablation not only of inducible tachycardias during the ablation procedure, but guided by the substrate that is most often key to the maintenance of these tachycardias, is superior to conventional treatment in reducing associated clinical events.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Line set strategy | Experimental | Pulmonary vein isolation, roof line, posterior wall isolation (posterior box), anterior septal line and cavo-tricuspid isthmus. |
|
| Conventional strategy | Active Comparator | Mapping and ablation of the present flutter and those that could be induced later until sinus rhythm is obtained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Line Set Strategy | Procedure | Substrate-guided ablation procedure of atypical atrial flutter |
|
| Measure | Description | Time Frame |
|---|---|---|
| Composite primary endpoint | Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major complications | Death, stroke/systemic embolism, tamponade, during the procedure and immediate post-procedure. | First month |
| Proportion of patients without recurrence of atrial arrhythmia at 18 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daniel Rodriguez Muñoz, MD, PhD | Contact | +34 917792742 | danielantonio.rodriguez@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Fernando Arribas Ynsaurriaga, MD, PhD | Hospital Universitario 12 de Octubre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario 12 de Octubre | Recruiting | Madrid | 28041 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42207412 | Derived | Rodriguez-Munoz D, Cobarro L, Lopez-Alacid I, Negreira-Caamano M, Gomez-Burgueno L, Ramos-Jimenez J, Rajjoub Al-Mahdi EA, Marco Del Castillo A, Borrego-Bernabe L, Delgado J, Salguero-Bodes R, Arribas-Ynsaurriaga F. Substrate ablation as concomitant treatment for left atrial macroreentrant tachycardia (SLICE-LAMRT): rationale and study design. J Interv Card Electrophysiol. 2026 May 28. doi: 10.1007/s10840-026-02363-1. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
The double-blind status will be established for the patient and the person responsible for the follow-up and clinical evaluation, who will never know the arm to which the patient has been randomized.
Logically, this randomization will be known to the operator who will carry out the intervention, which will be performed on the basis of two treatment schemes.
| Conventional strategy | Procedure | Electrical activation-guided ablation |
|
Maintainance of sinus rhythm by ablation, without requiring electrical cardioversion.
| 18 months |
| Procedure duration | Procedure duration, radiofrequency time, left atrial time (from transseptal puncture to left atrial catheter removal), fluoroscopy time. | In the procedure |
| Unplanned cardiovascular hospitalisation | Unplanned cardiovascular hospitalisation | 18 months |
| Unplanned hospitalization for any cause. | Unplanned hospitalization for any cause. | 18 months |
| All-cause mortality | Mortality due to any cause | 18 months |
| Cardiovascular mortality | Mortality due to cardiovascular causes | 18 months |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |