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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.
La Paz University Hospital, Department of Cardiology
Madrid, Spain
RECRUITINGProportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
Daily 1-lead 30 seconds ECG samples.
Time frame: 1 year follow-up
Acute success.
Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration ≥3 min).
Time frame: Acute intraprocedural.
Non-inducibility.
Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure.
Time frame: Acute intraprocedural.
Procedure duration.
From vein puncture up to seaths withdrawal.
Time frame: Acute intraprocedural.
Left atrial dwell time.
From transeptal puncture up to catheters withdrawal from the left atrium.
Time frame: Acute intraprocedural.
Safety.
Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism.
Time frame: Acute a 1 month after ablation (procedure-related complications).
Hospitalization.
Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up.
Time frame: 1 year.
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