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

Arrhythmias, Cardiac Clinical Trial

— FLUTMALINE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05063032
• Other study ID #: 5825 v 3.0, 3030th March 2021
• Status: Recruiting
• Phase: N/A
• Start date: January 28, 2022
• Est. completion date: October 1, 2024

Study information

• Verified date: January 2024
• Source: Hospital Universitario La Paz
• Contact: Sergio C Castrejón, PhD
• Phone: +34 659048245
• Email: lapaz[@]arritmias.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Flutter

Intervention

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

Locations

Country	Name	City	State
Spain	La Paz University Hospital, Department of Cardiology	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

Outcome

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