Ablation treatment for atypical atrial flutter
Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia - SLICE LAMRT
This study is testing if a new type of heart procedure can help adults with atypical atrial flutter have fewer heart rhythm problems compared to a standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario 12 de Octubre Academic / other |
| Locations | 1 site (Madrid) |
| Trial ID | NCT05842499 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the safety and effectiveness of a substrate-guided ablation procedure compared to a conventional electrical activity-guided strategy in patients with atypical atrial flutter suspected to originate from the left atrium. It is a multicenter, prospective, randomized, double-blind trial involving patients over 18 years old. The primary goal is to determine which method better reduces the recurrence of atrial arrhythmias and prolongs the time to the first recurrence of these conditions. The study will utilize advanced mapping systems and controlled lesion techniques to interrupt reentrant circuits associated with these arrhythmias.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with atypical flutter of suspected left atrial origin.
Not a fit: Patients with congenital heart disease or those with right-origin flutter may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the recurrence of atrial arrhythmias in patients with atypical atrial flutter.
How similar studies have performed: Previous studies have shown promising results with substrate-guided ablation techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Atypical flutter with positive F wave in V1, suspected left atrial origin. * Age ≥ 18 years * Capacity to understand the nature of the study, legal ability and willingness to give informed consent. Exclusion Criteria: * Simultaneous participation in a different trial. * Presence of congenital heart disease. * Suspected flutter of right origin or related to atriotomy scar from previous cardiac surgery. * NYHA IV functional class at the time of recruitment. * Contraindication to chronic anticoagulation or allergy/intolerance to heparin. * Uncontrolled hyperthyroidism. * Life expectancy less than 18 months. * Presence of heart disease that is expected to require surgery or heart transplantation within 18 months. * Pregnancy or the prospect of it in the next 18 months. * Left atrium without pathological substrate: area ≥ 4 cm2 of low voltages (\<0.5 mV) in the left atrium. * Severe fragility (Clinical Frailty Score ≥ 7).
Where this trial is running
Madrid
- Hospital Universitario 12 de Octubre — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Daniel Rodriguez Muñoz, MD, PhD
- Email: danielantonio.rodriguez@salud.madrid.org
- Phone: +34 917792742
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.