Atrial FibrillationNCT01896570
Role of Subsequent Atrial Tachycardia in Mechanisms of Persistent AF
An observational study of Atrial Fibrillation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
In this study, the investigators aim to examine the prognostic role of subsequent Atrial Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the investigators compare patients who were randomly assigned to either undergo cardioversion after AF has been terminated to AT or further ablation… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Catheter ablation of subsequent atrial tachycardia
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Mar 2013
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with persistent AF
Who may be able to join
- persistent AF for at least 1 months,
- age > 18 years,
- refractory to drug therapy,
- no prior ablation
Who cannot join
- prior AF ablation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital Eppendorf, Dept. of Electrophysiology
Hamburg, D-20246
About this study
Official title: The Prognostic Role of Subsequent Atrial Tachycardias Occurring After Atrial Fibrillation Termination: A Prospective Randomized Trial
In this study, the investigators aim to examine the prognostic role of subsequent Atrial Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the investigators compare patients who were randomly assigned to either undergo cardioversion after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.
- Conditions
- Atrial Fibrillation
- Being tested
- Catheter ablation of subsequent atrial tachycardia
- Keywords
- atrial fibrillation, catheter ablation, subsequent atrial tachycardia, mechanisms
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter ablation of subsequent atrial tachycardiaProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A: cardioversion at AT | after achievement of AT, pts were cardioverted | |
| Group B: ablation to SR | After AT has been achieved, all subsequent AT were ablated with the endpoint of procedural SR termination Receives: Procedure: Catheter ablation of subsequent atrial tachycardia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arrhythmia-free survival
Measured: 24 months after enrolment
Secondary outcomes (1)
Type of Arrhythmia recurrence
Measured: 24 months after enrolement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study startJun 2009
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies 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
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Rostock, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01896570
- Sponsor's protocol ID
- Ciritical endpoint HH
- Status last verified
- Jul 2013
- First submitted
- 6 Jul 2013
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rostock T, Salukhe TV, Hoffmann BA, Steven D, Berner I, Mullerleile K, Theis C, Bock K, Servatius H, Sultan A, Willems S. Prognostic role of subsequent atrial tachycardias occurring during ablation of persistent atrial fibrillation: a prospective randomized trial. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1059-65. doi: 10.1161/CIRCEP.113.001019. Epub 2013 Oct 25.
PubMed 24162833
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prognostic Role of Subsequent Atrial Tachycardias Occurring After Atrial Fibrillation Termination: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT01896570
- Acronym / sponsor ID
- Ciritical endpoint HH
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, catheter ablation, subsequent atrial tachycardia, mechanisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Mar 2013 (actual)
- First posted
- 11 Jul 2013 (estimated)
- 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.
In this study, the investigators aim to examine the prognostic role of subsequent Atrial Tachycardias (ATs) in the mechanisms of atrial fibrillation (AF). Therefore, the investigators compare patients who were randomly assigned to either undergo cardioversion after AF has been terminated to AT or further ablation until the achievement of sinus rhythm.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: cardioversion at AT | – | –after achievement of AT, pts were cardioverted |
| Group B: ablation to SR | – | Procedure: Catheter ablation of subsequent atrial tachycardiaAfter AT has been achieved, all subsequent AT were ablated with the endpoint of procedural SR termination |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with persistent AF
Key inclusion criteria (4 listed)
- persistent AF for at least 1 months,
- age > 18 years,
- refractory to drug therapy,
- no prior ablation
Key exclusion criteria (1 listed)
- prior AF ablation
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 |
|---|---|---|
| Catheter ablation of subsequent atrial tachycardia | Procedure or surgery | Group B: ablation to SR |
Primary outcome
Arrhythmia-free survival
Time frame: 24 months after enrolment
1 secondary outcome
Type of Arrhythmia recurrence
Time frame: 24 months after enrolement
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 11 Jul 2013.
- Derived from this study: PubMed 24162833Rostock T, Salukhe TV, Hoffmann BA, Steven D, Berner I, Mullerleile K, Theis C, Bock K, Servatius H, Sultan A, Willems S. Prognostic role of subsequent atrial tachycardias occurring during ablation of persistent atrial fibrillation: a prospective randomized trial. Circ Arrhythm Electrophysiol. 2013 Dec;6(6):1059-65. doi: 10.1161/CIRCEP.113.001019. Epub 2013 Oct 25.
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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 Atrial Fibrillation, run by Johannes Gutenberg University Mainz 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 4 inclusion and 1 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 11 Jul 2013. 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?
Arrhythmia-free survival (time frame: 24 months after enrolment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01896570, which also lists 1 linked publication.
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 11 Jul 2013.