Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation. (FLUTMALINE)

Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial

Unicenter, 1:1 randomized, open-labelled clinical trial comparing left atrial flutter ablation using high density mapping or strict lineal ablation. Main outcome: arrhythmia recurrences over 1 year follow-up with daily 1-lead 30 seconds ECG samples.

Study Overview

• Status: Recruiting
• Conditions: Arrhythmias, Cardiac
• Intervention / Treatment: Other: Radiofrecuency ablation

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sergio C Castrejón, PhD; Phone Number: +34 659048245; Email: lapaz@arritmias.net

Study Locations

• Spain
  • Madrid, Spain
    • Recruiting
    • La Paz University Hospital, Department of Cardiology
    • Contact: José Luis Merino, MD; Phone Number: +34 912071301; Email: lapaz@arritmias.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

• Left atrial flutter1 inducible during electrophysiological evaluation.
• Clinical indication for ablation: a) symptoms (palpitations, dizziness, syncope, breathlessness, derangement, heart failure), tachymiopathy, b) poor heart rate control, or c) recurrence after electrical cardioversion or failure of one antiarrhythmic drug.

• Informed consent.

  1. Patients will be enrolled if LAFL is clinically suspected but finally randomized if this mechanism is established by electrophysiologic evaluation according to the criteria stated above.

Exclusion criteria

• Previous ablation of LAFL.
• Previous linear ablation in the LA except for pulmonary vein isolation.
• Absolute contraindication for oral anticoagulation.
• Stroke or acute coronary syndrome less than 3 months before ablation.
• Complex congenital heart disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High-density mapping guided ablation; High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation.	Other: Radiofrecuency ablation; Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.
Active Comparator: Empirical linear ablation; Empirical predefined set of linear ablation.	Other: Radiofrecuency ablation; Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.	Daily 1-lead 30 seconds ECG samples.	1 year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute success.	Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration ≥3 min).	Acute intraprocedural.
Non-inducibility.	Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure.	Acute intraprocedural.
Procedure duration.	From vein puncture up to seaths withdrawal.	Acute intraprocedural.
Left atrial dwell time.	From transeptal puncture up to catheters withdrawal from the left atrium.	Acute intraprocedural.
Safety.	Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism.	Acute a 1 month after ablation (procedure-related complications).
Hospitalization.	Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up.	1 year.

Collaborators and Investigators

• Sponsor: Hospital Universitario La Paz

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: September 7, 2021
• First Submitted That Met QC Criteria: September 22, 2021
• First Posted (Actual): September 30, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Linear ablation; Left atrial flutter; High-density mapping
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Flutter
• Other Study ID Numbers: 5825 v 3.0, 3030th March 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No