Atrial FibrillationSLICE-LAMRTNCT05842499
Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia
A study testing Line Set Strategy and Conventional strategy in people with Atrial Fibrillation, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Line Set Strategy and Conventional strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 15 Jun 2021to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Daniel Rodríguez Muñoz, MD, PhD, +34 917792742, danielantonio.rodriguez@salud.madrid.org
About this study
Official title: Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia - SLICE LAMRT
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.
Read the detailed description
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.
- Conditions
- Atrial Fibrillation
- Being tested
- Line Set Strategy, Conventional strategy
- Keywords
- Atypical atrial flutter, Ablation, Pulmonary veins, Macroreentrant Tachycardia, Scar, Atypical flutter
- Medical subject headings
- Atrial Fibrillation, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Line Set StrategyProcedure or surgery
Substrate-guided ablation procedure of atypical atrial flutter
Conventional strategyProcedure or surgery
Electrical activation-guided ablation
| Study group | Role | What they receive |
|---|---|---|
| Line set strategy | Experimental | Pulmonary vein isolation, roof line, posterior wall isolation (posterior box), anterior septal line and cavo-tricuspid isthmus. Receives: Procedure: Line Set Strategy |
| Conventional strategy | Active comparator | Mapping and ablation of the present flutter and those that could be induced later until sinus rhythm is obtained. Receives: Procedure: Conventional strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint
Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation
Measured: 18 months
Secondary outcomes (7)
Major complications
Death, stroke/systemic embolism, tamponade, during the procedure and immediate post-procedure.
Measured: First month
Proportion of patients without recurrence of atrial arrhythmia at 18 months
Maintainance of sinus rhythm by ablation, without requiring electrical cardioversion.
Measured: 18 months
Procedure duration
Procedure duration, radiofrequency time, left atrial time (from transseptal puncture to left atrial catheter removal), fluoroscopy time.
Measured: In the procedure
Unplanned cardiovascular hospitalisation
Unplanned cardiovascular hospitalisation
Measured: 18 months
Unplanned hospitalization for any cause.
Unplanned hospitalization for any cause.
Measured: 18 months
All-cause mortality
Mortality due to any cause
Measured: 18 months
Cardiovascular mortality
Mortality due to cardiovascular causes
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 Jun 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Rodríguez Muñoz, Hospital Universitario 12 de Octubre
- Investigators
- Fernando Arribas Ynsaurriaga, MD, PhD, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842499
- Sponsor's protocol ID
- SLICE-LAMRT
- Acronym
- SLICE-LAMRT
- Status last verified
- Jul 2023
- First submitted
- 24 Apr 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42207412
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia - SLICE LAMRT
- ClinicalTrials.gov ID
- NCT05842499
- Acronym / sponsor ID
- SLICE-LAMRT / SLICE-LAMRT
- Conditions
- Atrial Fibrillation
- Keywords
- Atypical atrial flutter, Ablation, Pulmonary veins, Macroreentrant Tachycardia, Scar, Atypical flutter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Line set strategy | Experimental | Procedure: Line Set StrategyPulmonary vein isolation, roof line, posterior wall isolation (posterior box), anterior septal line and cavo-tricuspid isthmus. |
| Conventional strategy | Active comparator | Procedure: Conventional strategyMapping and ablation of the present flutter and those that could be induced later until sinus rhythm is obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Line Set StrategySubstrate-guided ablation procedure of atypical atrial flutter | Procedure or surgery | Line set strategy |
| Conventional strategyElectrical activation-guided ablation | Procedure or surgery | Conventional strategy |
Primary outcome
Composite primary endpoint
Time frame: 18 months
Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation
7 secondary outcomes
Major complications
Time frame: First month
Proportion of patients without recurrence of atrial arrhythmia at 18 months
Time frame: 18 months
Procedure duration
Time frame: In the procedure
Unplanned cardiovascular hospitalisation
Time frame: 18 months
Unplanned hospitalization for any cause.
Time frame: 18 months
All-cause mortality
Time frame: 18 months
Cardiovascular mortality
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Derived from this study: PubMed 42207412Rodriguez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Arribas Ynsaurriaga, MD, PhD study chair
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Line Set Strategy and Conventional strategy in people with Atrial Fibrillation, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel Rodriguez Muñoz, MD, PhD (+34 917792742, danielantonio.rodriguez@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2023.