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Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia (SLICE-LAMRT)

Primary Purpose

Atrial Fibrillation

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Line Set Strategy
Conventional strategy
Sponsored by
Hospital Universitario 12 de Octubre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atypical atrial flutter, Ablation, Pulmonary veins, Macroreentrant Tachycardia, Scar, Atypical flutter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital Universitario 12 de OctubreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Line set strategy

Conventional strategy

Arm Description

Pulmonary vein isolation, roof line, posterior wall isolation (posterior box), anterior septal line and cavo-tricuspid isthmus.

Mapping and ablation of the present flutter and those that could be induced later until sinus rhythm is obtained.

Outcomes

Primary Outcome Measures

Composite primary endpoint
Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation

Secondary Outcome Measures

Major complications
Death, stroke/systemic embolism, tamponade, during the procedure and immediate post-procedure.
Proportion of patients without recurrence of atrial arrhythmia at 18 months
Maintainance of sinus rhythm by ablation, without requiring electrical cardioversion.
Procedure duration
Procedure duration, radiofrequency time, left atrial time (from transseptal puncture to left atrial catheter removal), fluoroscopy time.
Unplanned cardiovascular hospitalisation
Unplanned cardiovascular hospitalisation
Unplanned hospitalization for any cause.
Unplanned hospitalization for any cause.
All-cause mortality
Mortality due to any cause
Cardiovascular mortality
Mortality due to cardiovascular causes

Full Information

First Posted
April 24, 2023
Last Updated
July 9, 2023
Sponsor
Hospital Universitario 12 de Octubre
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1. Study Identification

Unique Protocol Identification Number
NCT05842499
Brief Title
Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia
Acronym
SLICE-LAMRT
Official Title
Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia - SLICE LAMRT
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 15, 2021 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario 12 de Octubre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Atypical atrial flutter, Ablation, Pulmonary veins, Macroreentrant Tachycardia, Scar, Atypical flutter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Line set strategy
Arm Type
Experimental
Arm Description
Pulmonary vein isolation, roof line, posterior wall isolation (posterior box), anterior septal line and cavo-tricuspid isthmus.
Arm Title
Conventional strategy
Arm Type
Active Comparator
Arm Description
Mapping and ablation of the present flutter and those that could be induced later until sinus rhythm is obtained.
Intervention Type
Procedure
Intervention Name(s)
Line Set Strategy
Intervention Description
Substrate-guided ablation procedure of atypical atrial flutter
Intervention Type
Procedure
Intervention Name(s)
Conventional strategy
Intervention Description
Electrical activation-guided ablation
Primary Outcome Measure Information:
Title
Composite primary endpoint
Description
Time to first episode of sustained atrial arrhythmia in the absence of pharmacological antiarrhythmic treatment or new ablation
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Major complications
Description
Death, stroke/systemic embolism, tamponade, during the procedure and immediate post-procedure.
Time Frame
First month
Title
Proportion of patients without recurrence of atrial arrhythmia at 18 months
Description
Maintainance of sinus rhythm by ablation, without requiring electrical cardioversion.
Time Frame
18 months
Title
Procedure duration
Description
Procedure duration, radiofrequency time, left atrial time (from transseptal puncture to left atrial catheter removal), fluoroscopy time.
Time Frame
In the procedure
Title
Unplanned cardiovascular hospitalisation
Description
Unplanned cardiovascular hospitalisation
Time Frame
18 months
Title
Unplanned hospitalization for any cause.
Description
Unplanned hospitalization for any cause.
Time Frame
18 months
Title
All-cause mortality
Description
Mortality due to any cause
Time Frame
18 months
Title
Cardiovascular mortality
Description
Mortality due to cardiovascular causes
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Rodriguez Muñoz, MD, PhD
Phone
+34 917792742
Email
danielantonio.rodriguez@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Arribas Ynsaurriaga, MD, PhD
Organizational Affiliation
Hospital Universitario 12 de Octubre
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Rodríguez Muñoz, MD, PhD
Phone
+34 917792742
Email
danielantonio.rodriguez@salud.madrid.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Substrate abLatIon as Concomitant trEatment for Left Atrial Macroreentrant Tachycardia

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