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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arrhythmias, Cardiac

Intervention / Treatment
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* Other: Radiofrecuency ablation


Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1:1 parallell, randomized, controlled, open-label, single center clinical trial.
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Left atrial flutter, Linear ablation, High-density mapping