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Clinical Trials/NCT05063032
NCT05063032
Recruiting
Not Applicable

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

Hospital Universitario La Paz1 site in 1 country100 target enrollmentJanuary 28, 2022
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ConditionsArrhythmias, Cardiac

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Arrhythmias, Cardiac
Sponsor
Hospital Universitario La Paz
Enrollment
100
Locations
1
Primary Endpoint
Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 28, 2022
End Date
October 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Sergio Castrejón-Castrejón

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

Hospital Universitario La Paz

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Proportion of patients without sustained (≥30 s) atrial arrhythmia episodes over 1-year follow-up in each group.

Time Frame: 1 year follow-up

Daily 1-lead 30 seconds ECG samples.

Secondary Outcomes

  • Safety.(Acute a 1 month after ablation (procedure-related complications).)
  • Acute success.(Acute intraprocedural.)
  • Non-inducibility.(Acute intraprocedural.)
  • Hospitalization.(1 year.)
  • Procedure duration.(Acute intraprocedural.)
  • Left atrial dwell time.(Acute intraprocedural.)

Study Sites (1)

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