Outcome of Induced Atypical Atrial Flutter

NCT ID: NCT06323499

Last Updated: 2024-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tachyarrhythmia Atypical Atrial Flutter Induction of Arryhthmia Clinical Outcome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Induced atypical atrial flutter

Sinus rhythm when starting the procedure, so atypical atrial flutter had to be induced.

Induction of atypical atrial flutter

Intervention Type PROCEDURE

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.

No interventions assigned to this group

Interventions

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Induction of atypical atrial flutter

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Essen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Essen

Essen, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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UK Essen

Identifier Type: -

Identifier Source: org_study_id

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