NCT05842499

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable atrial-fibrillation

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable atrial-fibrillation

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

4.6 years

First QC Date

April 24, 2023

Last Update Submit

July 9, 2023

Conditions

Atrial Fibrillation

Keywords

Atypical atrial flutterAblationPulmonary veinsMacroreentrant TachycardiaScarAtypical flutter

Outcome Measures

Primary Outcomes (1)

  • Composite primary endpoint

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

    18 months

Secondary Outcomes (7)

  • Major complications

    First month

  • Proportion of patients without recurrence of atrial arrhythmia at 18 months

    18 months

  • Procedure duration

    In the procedure

  • Unplanned cardiovascular hospitalisation

    18 months

  • Unplanned hospitalization for any cause.

    18 months

  • +2 more secondary outcomes

Study Arms (2)

Line set strategy

EXPERIMENTAL

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

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.

Procedure: Conventional strategy

Interventions

Line Set StrategyPROCEDURE

Substrate-guided ablation procedure of atypical atrial flutter

Line set strategy
Conventional strategyPROCEDURE

Electrical activation-guided ablation

Conventional strategy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationCicatrix

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFibrosis

Study Officials

  • Fernando Arribas Ynsaurriaga, MD, PhD

    Hospital Universitario 12 de Octubre

    STUDY CHAIR

Central Study Contacts

Daniel Rodriguez Muñoz, MD, PhD

CONTACT

+34 917792742danielantonio.rodriguez@salud.madrid.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 6, 2023

Study Start

June 15, 2021

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)