Outcome of Induced Atypical Atrial Flutter

April 22, 2024 updated by: University Hospital, Essen

Outcome After Ablation of Atypical Atrial Flutter: is Induction a Feasible Approach?

Background: Atypical atrial flutter (AAF) is an increasingly relevant clinical problem. Despite advancements in mapping and ablation techniques, the general management of these patients remain challenging especially when mapping cannot be performed during ongoing arrhythmia. There are no data whether induction of AAF is a feasible approach in these cases.

Methods: The investigators retrospectively analyzed patients who underwent catheter ablation of AAF and compared procedural results between patients with ongoing tachycardia when starting the procedure and patients with induced AAF.

For this retrospective study, the investigators analyzed patients undergoing ablation of AAF between April 2018 and January 2021 that were identified from the ablation database at the West German Heart and Vascular Center, Essen. All patients were followed up in the outpatient clinic as part of the clinical standard routine or contacted by telephone to assess the occurrence of clinical recurrence of any arrhythmia. In case the documentation was not performed at the institution, relevant documents and ECGs were requested and reviewed.

This single-center cohort study was conducted at the University Hospital Essen, Germany, in accordance with the Declaration of Helsinki and its amendments and was approved by the institutional review board of the University of Essen (number 21-10341-BO). Written informed consent was obtained from all study participants.

The primary study endpoint was to evaluate the outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. Furthermore, the investigators analyzed the type of recurrence during follow-up as well as the occurrence and results of repeat ablations at the institution. The investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure.

Study Overview

Study Type

Observational

Enrollment (Actual)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • University Hospital Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptomatic, documented atypical atrial flutter undergoing ablation.

Description

Inclusion Criteria:

  • >18 years
  • symptomatic atypical atrial flutter and electrophysiological study with ablation

Exclusion Criteria:

  • inability to comply with follow up
  • participation in another trial that may interfere

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Induced atypical atrial flutter
Sinus rhythm when starting the procedure, so atypical atrial flutter had to be induced.
Electrophysiological study with induction of atypical atrial flutter. When the induction was successful, ablation of arrhythmia was performed similar to the control group.
Ongoing atrial flutter
Atypical atrial flutter was already ongoing when starting the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure.
Time Frame: April 2018 - October 2021
Recurrence rate of atrial arrhythmias following induced Atrial Fibrillation (AAF) ablation compared to ongoing AAF. The primary outcome measure involves performing ECGs to ascertain the rhythm. When an atrial arrhythmia is confirmed, the patient is categorized as having recurrent arrhythmia. The recurrence rate is calculated as the proportion of cases with documented arrhythmia out of all cases.
April 2018 - October 2021

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Type of recurrence during follow-up
Time Frame: April 2018 - October 2021
Type of arrhythmia in follow-up: atrial fibrillation, atypical atrial flutter or both. ECGs will be used to determine the type of arrhythmia.
April 2018 - October 2021
Occurrence and results of repeat ablations at our institution
Time Frame: April 2018 - October 2021
If patients were re-ablated at the institution, the investigators also evaluated if the recurrent AAF form was the same or de-novo compared to the AAF during previous procedure. Electrophysiological characteristics during procedure are used to determine the form of arrhythmia.
April 2018 - October 2021

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

October 31, 2021

Study Completion (Actual)

October 31, 2021

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 14, 2024

First Posted (Actual)

March 21, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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