Atrial FibrillationATTAC CFAENCT01229033
Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF
A study testing Ablation and Cardioversion in people with Atrial Fibrillation and Ablation, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Ablation, Atrial Flutter
- What is being tested?
- Ablation and Cardioversion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 2 sitesGermany
- Study dates
- Jan 2010to Jan 2014
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (>=18 und < 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR).
- At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
- Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR > 2..
- Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
- Atrial tachycardia occurring during ablation of CFAE (defined as CL > 200 msec und stable activation sequence).
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Klinikum Karlsruhe
Karlsruhe, 76133
Deutsches Herzzentrum München
München, 80636
About this study
Official title: Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial
Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum.
When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear.
In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).
- Conditions
- Atrial Fibrillation, Ablation, Atrial Flutter
- Being tested
- Ablation, Cardioversion
- Keywords
- Atrial fibrillation, ablation, atrial flutter
- Medical subject headings
- Atrial Fibrillation, Atrial Flutter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AblationProcedure or surgery
Ablation of atrial tachycardia
CardioversionProcedure or surgery
Cardioversion of atrial tachycardia
| Study group | Role | What they receive |
|---|---|---|
| Ablation | Active comparator | Ablation of atrial tachycardia Receives: Procedure: Ablation |
| Cardioversion | Active comparator | Cardioversion of atrial tachycardia Receives: Procedure: Cardioversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial tachyarrhythmia
Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.
Secondary outcomes (1)
Procedural and safety data
- Duration of left atrial procedure, time of ablation, time of radiation and radiation dose from randomization until the end of the procedure.
- In case of recurrence, characteristic of predominant tachyarrhythmia (AF or AT).
- Safety parameters (pericardial tamponade, thrombembolic complications).
- Number of re-ablations.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
- Investigators
- Isabel Deisenhofer, MD, Study chair, Deutsches Herzzentrum MünchenClemens Jilek, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229033
- Sponsor's protocol ID
- GER-EP-001
- Acronym
- ATTAC CFAE
- Status last verified
- Apr 2017
- First submitted
- 26 Oct 2010
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ablating Atrial Tachycardias Occuring During Ablation of Complex Fractionated Electrograms in Persistent AF - ATTAC CFAE Trial
- ClinicalTrials.gov ID
- NCT01229033
- Acronym / sponsor ID
- ATTAC CFAE / GER-EP-001
- Conditions
- Atrial Fibrillation, Ablation, Atrial Flutter
- Keywords
- Atrial fibrillation, ablation, atrial flutter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Collaborators
- Klinik für Kardiologie, Klinikum Karlsruhe, Prof. Dr. C. Schmitt
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 27 Oct 2010 (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.
Catheter ablation has proven to be an effective treatment option in patients suffering from symptomatic persistent atrial fibrillation (AF). Catheter ablation consists of two major steps: (1) Isolation of pulmonary veins to abolish the trigger of atrial fibrillation and (2) modification of left atrial and eventually right atrial substrate by ablation of complex fractionated atrial electrograms (CFAE). CFAE are mainly found at the ostia of the pulmonary veins, around the left atrial appendage, at the mitral annulus and the septum.
When ablating CFAE 40-65% of the patients show a regularization of AF to an atrial tachycardia (AT) that can be macro- or micro-reentrant (localized re-entry). Until now the significance of the AT is unclear.
In the following study we examine the hypothesis that an ablation of AT occuring during CFAE ablation (group 1) significantly improves outcome defined as freedom of atrial arrhythmia (AF or AT) compared to patients that are cardioverted when AF has regularized to AT (group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ablation | Active comparator | Procedure: AblationAblation of atrial tachycardia |
| Cardioversion | Active comparator | Procedure: CardioversionCardioversion of atrial tachycardia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients (>=18 und < 80 years) with symptomatic persistent AF (AF episode enduring at least 7 days) but are successfully convertable in sinus rhythm (SR).
- At least one unsuccessful attempt of antiarrhythmic drug (betablocker or class I oder III).
- Oral anticoagulation with phenprocoumone or warfarine for at least 4 weeks prior to ablation with weekly documented INR > 2..
- Withdrawal of antiarrhythmic drugs at least 3 half times prior to ablation except amiodarone.
- Atrial tachycardia occurring during ablation of CFAE (defined as CL > 200 msec und stable activation sequence).
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| AblationAblation of atrial tachycardia | Procedure or surgery | Ablation |
| CardioversionCardioversion of atrial tachycardia | Procedure or surgery | Cardioversion |
Primary outcome
Freedom from atrial tachyarrhythmia
Documented freedom from atrial tachyarrhythmia (AF or AT) during follow-up after first ablation.
1 secondary outcome
Procedural and safety data
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 Apr 2017.
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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.
Isabel Deisenhofer, MD study chair
Deutsches Herzzentrum München
Clemens Jilek, MD principal investigator
Deutsches Herzzentrum München
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation and Cardioversion in people with Atrial Fibrillation and Ablation, run by Deutsches Herzzentrum Muenchen at 2 sites 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 5 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Freedom from atrial tachyarrhythmia. 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 11 Apr 2017.