Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia (NCT05842499) | Clinical Trial Compass
UnknownNot Applicable
Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia
Spain128 participantsStarted 2021-06-15
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.