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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05063032

Acronym

FLUTMALINE

Enrollment

100

Registered

2021-09-30

Start date

2022-01-28

Completion date

2024-10-01

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmias, Cardiac

Keywords

Left atrial flutter, Linear ablation, High-density mapping

Brief summary

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.

Interventions

OTHERRadiofrecuency ablation

Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

1:1 parallell, randomized, controlled, open-label, single center clinical trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Contacts

Primary ContactSergio C Castrejón, PhD

lapaz@arritmias.net+34 659048245

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026