TachyarrhythmiaNCT06323499
Outcome of Induced Atypical Atrial Flutter
An observational study of Tachyarrhythmia and Atypical Atrial Flutter, run by University Hospital, Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tachyarrhythmia, Atypical Atrial Flutter, Induction of Arryhthmia
- What is being tested?
- Induction of atypical atrial flutter
- Type of treatment
- Surgery or procedure
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to 31 Oct 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic, documented atypical atrial flutter undergoing ablation.
Who may be able to join
- >18 years
- symptomatic atypical atrial flutter and electrophysiological study with ablation
Who cannot join
- inability to comply with follow up
- participation in another trial that may interfere
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Being tested
- Induction of atypical atrial flutter
- Medical subject headings
- Tachycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induction of atypical atrial flutterProcedure or surgery
Electrophysiological study with induction of atypical atrial flutter. When the induction was successful, ablation of arrhythmia was performed similar to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Induced atypical atrial flutter | Sinus rhythm when starting the procedure, so atypical atrial flutter had to be induced. Receives: Procedure: Induction of atypical atrial flutter | |
| Ongoing atrial flutter | Atypical atrial flutter was already ongoing when starting the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: April 2018 - October 2021
Secondary outcomes (2)
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.
Measured: April 2018 - October 2021
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.
Measured: April 2018 - October 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Apr 2018
- Primary completion31 Oct 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TachyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323499
- Sponsor's protocol ID
- UK Essen
- Status last verified
- Apr 2024
- First submitted
- 14 Mar 2024
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome After Ablation of Atypical Atrial Flutter: is Induction a Feasible Approach?
- ClinicalTrials.gov ID
- NCT06323499
- Acronym / sponsor ID
- UK Essen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induced atypical atrial flutter | – | Procedure: Induction of atypical atrial flutterSinus rhythm when starting the procedure, so atypical atrial flutter had to be induced. |
| Ongoing atrial flutter | – | –Atypical atrial flutter was already ongoing when starting the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic, documented atypical atrial flutter undergoing ablation.
Key inclusion criteria (2 listed)
- >18 years
- symptomatic atypical atrial flutter and electrophysiological study with ablation
Key exclusion criteria (2 listed)
- inability to comply with follow up
- participation in another trial that may interfere
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Induction of atypical atrial flutterElectrophysiological study with induction of atypical atrial flutter. When the induction was successful, ablation of arrhythmia was performed similar to the control group. | Procedure or surgery | Induced atypical atrial flutter |
Primary outcome
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.
2 secondary outcomes
Type of recurrence during follow-up
Time frame: April 2018 - October 2021
Occurrence and results of repeat ablations at our institution
Time frame: April 2018 - October 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tachyarrhythmia and Atypical Atrial Flutter, run by University Hospital, Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Outcome of patients with induced AAF in comparison to patients with ongoing AAF when starting the procedure. (time frame: April 2018 - October 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.