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

NCT ID: NCT05063032

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-28

Study Completion Date

2024-10-01

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.

Detailed Description

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Conditions

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Arrhythmias, Cardiac

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1:1 parallell, randomized, controlled, open-label, single center clinical trial.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-density mapping guided ablation

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

Group Type EXPERIMENTAL

Radiofrecuency ablation

Intervention Type OTHER

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

Empirical linear ablation

Empirical predefined set of linear ablation.

Group Type ACTIVE_COMPARATOR

Radiofrecuency ablation

Intervention Type OTHER

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

Interventions

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Radiofrecuency ablation

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

Intervention Type OTHER

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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role lead

Responsible Party

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Dr. Sergio Castrejón-Castrejón

Electrophysiologist, Principal investigator (togheter with Dr. José Luis Merino)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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La Paz University Hospital, Department of Cardiology

Madrid, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Sergio C Castrejón, PhD

Role: CONTACT

+34 659048245

Facility Contacts

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José Luis Merino, MD

Role: primary

+34 912071301

Other Identifiers

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5825 v 3.0, 3030th March 2021

Identifier Type: -

Identifier Source: org_study_id

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