Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia
NCT ID: NCT05842499
Last Updated: 2023-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2021-06-15
2026-01-01
Brief Summary
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The composite primary endpoint is time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Study Groups
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Line set strategy
Pulmonary vein isolation, roof line, posterior wall isolation (posterior box), anterior septal line and cavo-tricuspid isthmus.
Line Set Strategy
Substrate-guided ablation procedure of atypical atrial flutter
Conventional strategy
Mapping and ablation of the present flutter and those that could be induced later until sinus rhythm is obtained.
Conventional strategy
Electrical activation-guided ablation
Interventions
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Line Set Strategy
Substrate-guided ablation procedure of atypical atrial flutter
Conventional strategy
Electrical activation-guided ablation
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Capacity to understand the nature of the study, legal ability and willingness to give informed consent.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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Hospital Universitario 12 de Octubre
OTHER
Responsible Party
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Daniel Rodríguez Muñoz
Principal Investigator
Principal Investigators
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Fernando Arribas Ynsaurriaga, MD, PhD
Role: STUDY_CHAIR
Hospital Universitario 12 de Octubre
Locations
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Hospital Universitario 12 de Octubre
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SLICE-LAMRT
Identifier Type: -
Identifier Source: org_study_id
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