NCT06323499

Outcome of Induced Atypical Atrial Flutter

Completed Last updated 24 April 2024

What this trial tests

trial testing Induction of atypical atrial flutter in Tachyarrhythmia in 76 participants. Completed in 31 October 2021.

Timeline

1 April 2018

Primary endpoint
31 October 2021

31 October 2021

Quick facts

Lead sponsor	University Hospital, Essen
Status	Completed
Study type	OBSERVATIONAL
Enrollment	76
Start date	1 April 2018
Primary completion	31 October 2021
Estimated completion	31 October 2021
Sites	1 location across Germany

Drugs / interventions tested

• Induction of atypical atrial flutter

Conditions studied

• Tachyarrhythmia — all drugs for Tachyarrhythmia →
• Atypical Atrial Flutter — all drugs for Atypical Atrial Flutter →
• Induction of Arryhthmia — all drugs for Induction of Arryhthmia →
• Clinical Outcome — all drugs for Clinical Outcome →

Sponsor

University Hospital, Essen

Who can join

18 and older, any sex, with Tachyarrhythmia or Atypical Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Outcome after ablation of atypical atrial flutter: Is induction a feasible approach?
   Vonderlin N, Siebermair J, Mahabadi AA, Dobrev D, et al · · 2024 · cited 2× · PMID 39238839 · DOI 10.1016/j.ijcha.2024.101489