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

Not Applicable

Recruiting

• Conditions: Arrhythmias, Cardiac
• Interventions: Other: Radiofrecuency ablation

• Registration Number: NCT05063032
• Lead Sponsor: Hospital Universitario La Paz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-22
• Study First Posted: 2021-09-30
• Study Start: 2022-01-28
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Empirical linear ablation	Radiofrecuency ablation	Empirical predefined set of linear ablation.
High-density mapping guided ablation	Radiofrecuency ablation	High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

La Paz University Hospital, Department of Cardiology; 🇪🇸 Madrid, Spain