- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06323499
Outcome of Induced Atypical Atrial Flutter
Outcome After Ablation of Atypical Atrial Flutter: is Induction a Feasible Approach?
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Nordrhein-Westfalen
-
Essen, Nordrhein-Westfalen, Germany, 45147
- University Hospital Essen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Induced atypical atrial flutter
Sinus rhythm when starting the procedure, so atypical atrial flutter had to be induced.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure.
Time Frame: April 2018 - October 2021
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Type of recurrence during follow-up
Time Frame: April 2018 - October 2021
|
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
|
|
Occurrence and results of repeat ablations at our institution
Time Frame: April 2018 - October 2021
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UK Essen
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tachyarrhythmia
-
Hartford HospitalUnknown
-
Biotronik SE & Co. KGCompletedVentricular TachyarrhythmiaGermany, Sweden
-
Sheba Medical CenterCompletedVentricular TachyarrhythmiaIsrael
-
Medtronic Cardiac Rhythm and Heart FailureMedtronicCompletedAtrial Fibrillation | Atrial Tachyarrhythmia
-
University of California, San DiegoNational Heart, Lung, and Blood Institute (NHLBI)CompletedAtrial Fibrillation | Atrial TachyarrhythmiaUnited States
-
Boston Scientific CorporationCompletedVentricular TachyarrhythmiasNew Zealand
-
Medtronic Cardiac Rhythm and Heart FailureMedtronicCompleted
-
University of California, San DiegoCompletedVentricular TachyarrhythmiasUnited States
-
Emory UniversityCompletedBradycardia, Atrial TachyarrhythmiaUnited States
-
Ochsner Health SystemBoston Scientific CorporationCompletedVentricular Fibrillation | Ventricular Tachycardia | CardiomyopathyUnited States
Clinical Trials on Induction of atypical atrial flutter
-
University Hospital, RouenMedtronicCompletedAtrial Fibrillation | Atrial FlutterFrance
-
Stiftung Institut fuer HerzinfarktforschungBoston Scientific CorporationCompleted
-
EPD Solutions, A Philips CompanyTerminated
-
University Hospital, RouenTerminated
-
Hospital Clinic of BarcelonaCompleted
-
University of CalgaryNot yet recruitingAtrial Flutter | Atrial Flutter Typical | Cavotricuspid Isthmus Dependent Macroreentry TachycardiaCanada
-
David B. De LurgioBoston Scientific CorporationCompletedAtrial Flutter | Cardiac Arrhythmias | Cardiac Catheter AblationUnited States
-
University of LeipzigPhilips Healthcare; Heart Center Leipzig - University Hospital; Imricor Medical...TerminatedAtrial FlutterGermany
-
Biosense Webster, Inc.CompletedAtrial FlutterUnited States
-
University Hospital, GenevaUnknownRadiofrequency Ablation | Typical Atrial Flutter | Irrigated CathetersSwitzerland