Outcome of Induced Atypical Atrial Flutter

NCT06323499 | Completed

• 1 other identifier: UK Essen
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Tachyarrhythmia; Atypical Atrial Flutter; Induction of Arryhthmia; Clinical Outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Type of recurrence during follow-up

  April 2018 - October 2021

• Occurrence and results of repeat ablations at our institution

  April 2018 - October 2021

Study Arms (2)

Induced atypical atrial flutter

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

Procedure: Induction of atypical atrial flutter

Ongoing atrial flutter

Atypical atrial flutter was already ongoing when starting the procedure.

Interventions

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.

Induced atypical atrial flutter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic, documented atypical atrial flutter undergoing ablation.

You may qualify if:

• \>18 years
• symptomatic atypical atrial flutter and electrophysiological study with ablation

You may not qualify if:

• inability to comply with follow up
• participation in another trial that may interfere

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (1)

University Hospital Essen

Essen, North Rhine-Westphalia, 45147, Germany

Location

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 21, 2024
• Study Start: April 1, 2018
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

DE (1)