Outcome of Induced Atypical Atrial Flutter

Tachyarrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06323499
• Other study ID #: UK Essen
• Status: Completed
• Start date: April 1, 2018
• Est. completion date: October 31, 2021

Study information

• Verified date: April 2024
• Source: University Hospital, Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: October 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Flutter
• Clinical Outcome
• Tachyarrhythmia
• Tachycardia

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Essen	Essen	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure.	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	Type of recurrence during follow-up	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
Secondary	Occurrence and results of repeat ablations at our institution	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