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

Madrid Health Service

Status: Enrolling

Conditions: Arrhythmias, Cardiac

Treatments: Other: Radiofrecuency ablation

Study type: Interventional

Funder types: Other

Identifiers

NCT05063032

5825 v 3.0, 3030th March 2021

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

High-density mapping guided ablation

Experimental group

Description:

High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation.

Treatment:

Other: Radiofrecuency ablation

Empirical linear ablation

Active Comparator group

Description:

Empirical predefined set of linear ablation.

Treatment:

Other: Radiofrecuency ablation