Atrial FibrillationREDO-AFNCT01229475
Stepwise Approach Versus Linear Ablation in Patients With Recurrence of Persistent Atrial Fibrillation
A study testing Ablation with stepwise approach and Linear ablation in people with Atrial Fibrillation and Recurrence, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Recurrence
- What is being tested?
- Ablation with stepwise approach and Linear ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to Dec 2013
- 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 with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
- with the last ablation procedure at least 3 months ago.
- at least one unsuccessful attempt of antiarrhythmic drug
- oral anticoagulation for at least 4 weeks prior to ablation
Who cannot join
- LA thrombus
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum München
Munich, 80636
Sonia Ammar, MD
About this study
Official title: Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation
Catheter ablation of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.
The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Recurrence
- Being tested
- Ablation with stepwise approach, Linear ablation
- Keywords
- Atrial fibrillation, recurrence, repeat procedure, linear ablation, stepwise approach
- Medical subject headings
- Atrial Fibrillation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ablation with stepwise approachProcedure or surgery
Stepwise approach for repeat AF ablation
Linear ablationProcedure or surgery
Linear ablation for AF ablation
| Study group | Role | What they receive |
|---|---|---|
| Stepwise approach | Active comparator | Stepwise approach for repeat AF ablation Receives: Procedure: Ablation with stepwise approach; Procedure: Linear ablation |
| Linear ablation | Active comparator | Linear ablation for repeat procedure in patients with recurrent atrial fibrillation Receives: Procedure: Ablation with stepwise approach; Procedure: Linear ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial arrhythmia
Documented freedom from atrial arrhythmia (AF or AT) during follow-up.
Secondary outcomes (1)
Procedural and safety data
- Duration of left atrial procedure, ablation time, fluoroscopy time.
- Complications
- Type of recurrent arrhythmia
- Number of reablation
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 startOct 2010
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Isabel Deisenhofer, MD, Study chair, Deutsches Herzzentrum MünchenSonia Ammar, MD, Principal investigator, Deutsches Herzzentrum München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01229475
- Sponsor's protocol ID
- GER-EP-003
- Acronym
- REDO-AF
- Status last verified
- Feb 2013
- First submitted
- 26 Oct 2010
- Last updated
- 1 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepwise Approach Versus Linear Ablation for Repeat Procedure in Patients With Recurrence of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01229475
- Acronym / sponsor ID
- REDO-AF / GER-EP-003
- Conditions
- Atrial Fibrillation, Recurrence
- Keywords
- Atrial fibrillation, recurrence, repeat procedure, linear ablation, stepwise approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- 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 of persistent atrial fibrillation (AF) remains a challenging procedure. Even in experienced centres, repeat interventions are necessary in up to 70 of patients to achieve sinus rhythm at a long-term follow-up.
While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for the ablation of paroxysmal and persistent AF ablation, different additional ablation strategies are used to achieve a modification of the substrate that perpetuates the arrhythmia: linear lesions (anterior and roof lines) or ablation of complex fractionated atrial electrograms (CFAE). In the stepwise approach PVI, CFAE ablation and/or LL are combined according to the presenting arrhythmia during procedure.
The aim of the study is to determine whether there is a difference in terms of freedom from arrhythmia between a stepwise approach and a linear ablation for repeat procedure in patient with recurrence of persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stepwise approach | Active comparator | Procedure: Ablation with stepwise approach, Procedure: Linear ablationStepwise approach for repeat AF ablation |
| Linear ablation | Active comparator | Procedure: Ablation with stepwise approach, Procedure: Linear ablationLinear ablation for repeat procedure in patients with recurrent atrial fibrillation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with recurrence of symptomatic persistent atrial fibrillation after at least one ablation procedure,
- with the last ablation procedure at least 3 months ago.
- at least one unsuccessful attempt of antiarrhythmic drug
- oral anticoagulation for at least 4 weeks prior to ablation
Key exclusion criteria (1 listed)
- LA thrombus
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 |
|---|---|---|
| Ablation with stepwise approachStepwise approach for repeat AF ablation | Procedure or surgery | Linear ablation, Stepwise approach |
| Linear ablationLinear ablation for AF ablation | Procedure or surgery | Linear ablation, Stepwise approach |
Primary outcome
Freedom from atrial arrhythmia
Documented freedom from atrial arrhythmia (AF or AT) during follow-up.
1 secondary outcome
Procedural and safety data
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2013.
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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.
Isabel Deisenhofer, MD study chair
Deutsches Herzzentrum München
Sonia Ammar, MD principal investigator
Deutsches Herzzentrum München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ablation with stepwise approach and Linear ablation in people with Atrial Fibrillation and Recurrence, run by Deutsches Herzzentrum Muenchen 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: status not confirmed, as of the sponsor's last update on 1 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Ammar, MD (+49891218 ext. 2020, ammar@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from atrial arrhythmia. 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 1 Mar 2013.