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

Primary Purpose

Arrhythmias, Cardiac

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radiofrecuency ablation
Sponsored by
Hospital Universitario La Paz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias, Cardiac focused on measuring Left atrial flutter, Linear ablation, High-density mapping

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • La Paz University Hospital, Department of CardiologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-density mapping guided ablation

Empirical linear ablation

Arm Description

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

Empirical predefined set of linear ablation.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 7, 2021
Last Updated
July 14, 2023
Sponsor
Hospital Universitario La Paz
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1. Study Identification

Unique Protocol Identification Number
NCT05063032
Brief Title
Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation.
Acronym
FLUTMALINE
Official Title
Left Atrial FLUTter: a Comparison of Ablation Guided by High-density MApping and Empirical LINEar Ablation - the FLUTMALINE Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario La Paz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac
Keywords
Left atrial flutter, Linear ablation, High-density mapping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
1:1 parallell, randomized, controlled, open-label, single center clinical trial.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-density mapping guided ablation
Arm Type
Experimental
Arm Description
High-density map and return-cycles map in order to localize the protected isthmus with precision for focal/minimal ablation.
Arm Title
Empirical linear ablation
Arm Type
Active Comparator
Arm Description
Empirical predefined set of linear ablation.
Intervention Type
Other
Intervention Name(s)
Radiofrecuency ablation
Intervention Description
Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.
Primary Outcome Measure Information:
Title
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
Description
Daily 1-lead 30 seconds ECG samples.
Time Frame
1 year follow-up
Secondary Outcome Measure Information:
Title
Acute success.
Description
Termination of all organized atrial arrhythmias (spontaneous or induced, organized and stable atrial arrhythmias with duration ≥3 min).
Time Frame
Acute intraprocedural.
Title
Non-inducibility.
Description
Non-inducibility of all organized atrial arrhythmias at the end of the ablation procedure.
Time Frame
Acute intraprocedural.
Title
Procedure duration.
Description
From vein puncture up to seaths withdrawal.
Time Frame
Acute intraprocedural.
Title
Left atrial dwell time.
Description
From transeptal puncture up to catheters withdrawal from the left atrium.
Time Frame
Acute intraprocedural.
Title
Safety.
Description
Incidence of compications: 1)vascular lesions, 2)cardiac tamponade, 3)embolism.
Time Frame
Acute a 1 month after ablation (procedure-related complications).
Title
Hospitalization.
Description
Number of hospitalizations due to atrial arrhythmia episodes at 1-year follow-up.
Time Frame
1 year.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio C Castrejón, PhD
Phone
+34 659048245
Email
lapaz@arritmias.net
Facility Information:
Facility Name
La Paz University Hospital, Department of Cardiology
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Luis Merino, MD
Phone
+34 912071301
Email
lapaz@arritmias.net

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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