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

NCT05063032 | Unknown

• 1 other identifier: 5825 v 3.0, 3030th March 2021
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Arrhythmias, Cardiac

Keywords

Left atrial flutter; Linear ablation; High-density mapping

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Acute success.

  Acute intraprocedural.

• Non-inducibility.

  Acute intraprocedural.

• Procedure duration.

  Acute intraprocedural.

• Left atrial dwell time.

  Acute intraprocedural.

• Safety.

  Acute a 1 month after ablation (procedure-related complications).

Study Arms (2)

High-density mapping guided ablation

EXPERIMENTAL

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

Other: Radiofrecuency ablation

Empirical linear ablation

ACTIVE COMPARATOR

Empirical predefined set of linear ablation.

Other: Radiofrecuency ablation

Interventions

Radiofrecuency ablation OTHER

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

Empirical linear ablation; High-density mapping guided ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Paz: lead

Study Sites (1)

La Paz University Hospital, Department of Cardiology

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sergio C Castrejón, PhD

CONTACT

+34 659048245; lapaz@arritmias.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Electrophysiologist, Principal investigator (togheter with Dr. José Luis Merino)

Model Details: 1:1 parallell, randomized, controlled, open-label, single center clinical trial.

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 30, 2021
• Study Start: January 28, 2022
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)