Clinical trial NCT06323499: Outcome of Induced Atypical Atrial Flutter
Official title: Outcome After Ablation of Atypical Atrial Flutter: is Induction a Feasible Approach?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tachyarrhythmia
Atypical Atrial Flutter
Induction of Arryhthmia
Clinical Outcome
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic, documented atypical atrial flutter undergoing ablation.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure.
timeFrame: April 2018 - October 2021
Secondary outcomes:
measure: Type of recurrence during follow-up
timeFrame: April 2018 - October 2021
measure: Occurrence and results of repeat ablations at our institution
timeFrame: April 2018 - October 2021
Other outcomes:
Locations:
city: Essen
country: Germany
facility: University Hospital Essen
state: Nordrhein-Westfalen
Study officials:
References: