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OpenTrials
Completed

NCT Number: NCT06323499

Outcome of Induced Atypical Atrial Flutter

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induction of atypical atrial flutter

Procedure

Electrophysiological study with induction of atypical atrial flutter. When the induction was successful, ablation of arrhythmia was performed similar to the control group.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Essen

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 21, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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