Atrial FibrillationPhase 4NCT00196157
Line Versus Spot Ablation in Persistent Atrial Fibrillation
A Phase 4 study testing linear anatomically oriented ablations and focal electrophysiological oriented ablations in people with Atrial Fibrillation, run by Deutsches Herzzentrum Muenchen at 1 site in Germany.
Trial summary
In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- linear anatomically oriented ablations and focal electrophysiological oriented ablations
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2004to Nov 2008
- Phase
- Phase 4
- 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
- age between 18 and 80 years
- symptomatic persistent (> 7 days lasting) atrial fibrillation
- at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
- oral anticoagulation (> 4 weeks prior to ablation)
Who cannot join
- moderate to severe valvular heart disease
- congenital heart disease
- LV-EF < 35%
- reversible cause for atrial fibrillation (e.g., hyperthyreosis)
- prior left atrial ablation or Maze operation
- left atrial thrombus
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Deutsches Herzzentrum Muenchen
Munich, 80636
Heidi Estner, MD, 0049 89 1218 2020, estner@dhm.mhn.de
Heidi Estner, MD
About this study
Official title: Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation
In this randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Read the detailed description
This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.
The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.
- Conditions
- Atrial Fibrillation
- Being tested
- linear anatomically oriented ablations, focal electrophysiological oriented ablations
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
linear anatomically oriented ablationsProcedure or surgery
linear lesions to ablate persistent atrial fibrillation
focal electrophysiological oriented ablationsProcedure or surgery
focal electrophysiologically guided ablations to treat persistent atrial fibrillation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | linear lesions to ablate persistent atrial fibrillation Receives: Procedure: linear anatomically oriented ablations |
| 2 | Experimental | focal electrophysiologically guided ablations to treat persistent atrial fibrillation Receives: Procedure: focal electrophysiological oriented ablations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sinus rhythm in follow-up
Measured: Sinus rhythm in follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionMay 2008 (estimated)
- Study completionNov 2008 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Investigators
- Claus Schmitt, MD, Study chair, Deutsches Herzzentrum MuenchenHeidi Estner, MD, Principal investigator, Deutsches Herzzentrum Muenchen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00196157
- Sponsor's protocol ID
- GE IDE No. C00604
- Status last verified
- May 2009
- First submitted
- 12 Sep 2005
- Last updated
- 29 May 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linear Anatomically Versus Focal Electrophysiologically Guided Substrate Ablation in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT00196157
- Acronym / sponsor ID
- GE IDE No. C00604
- Conditions
- Atrial Fibrillation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- May 2008 (estimated)
- Study completion
- Nov 2008 (estimated)
- First posted
- 20 Sep 2005 (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 randomized study dealing with the ablative treatment of persistent atrial fibrillation, two ablation strategies are compared: a more anatomically guided linear ablation scheme versus an electrophysiological guided focal ablation strategy aiming at the electrical isolating of the pulmonary veins and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Detailed description
This randomized study deals with two different ablative treatment strategies for persistent atrial fibrillation: a more anatomically guided linear ablation scheme with encircling of the ipsilateral pulmonary veins (PV), a left atrial roof line and an anterior line bridging the anterior mitral anulus to the ostium of the left superior PV versus an electrophysiological guided focal ablation strategy aiming at isolating, electrically, the PV and ablating areas of fragmented intracardiac electrograms thought to maintain atrial fibrillation.
Both ablation approaches contain isolation of the most common source of triggering foci, i.e., the pulmonary veins and additional modification of the substrate maintaining atrial fibrillation.
The study endpoint is a combined efficacy/safety analysis. Extensive follow-up with three-monthly 7 days holter ECG is provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: linear anatomically oriented ablationslinear lesions to ablate persistent atrial fibrillation |
| 2 | Experimental | Procedure: focal electrophysiological oriented ablationsfocal electrophysiologically guided ablations to treat persistent 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)
- age between 18 and 80 years
- symptomatic persistent (> 7 days lasting) atrial fibrillation
- at least one unsuccessful cardioversion or atrial fibrillation relapse in the first 3 months after cardioversion despite antiarrhythmic drug therapy
- oral anticoagulation (> 4 weeks prior to ablation)
Key exclusion criteria (6 listed)
- moderate to severe valvular heart disease
- congenital heart disease
- LV-EF < 35%
- reversible cause for atrial fibrillation (e.g., hyperthyreosis)
- prior left atrial ablation or Maze operation
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 |
|---|---|---|
| linear anatomically oriented ablationslinear lesions to ablate persistent atrial fibrillation | Procedure or surgery | 1 |
| focal electrophysiological oriented ablationsfocal electrophysiologically guided ablations to treat persistent atrial fibrillation | Procedure or surgery | 2 |
Primary outcome
Sinus rhythm in follow-up
Time frame: Sinus rhythm in follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2009.
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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.
Claus Schmitt, MD study chair
Deutsches Herzzentrum Muenchen
Heidi Estner, MD principal investigator
Deutsches Herzzentrum Muenchen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing linear anatomically oriented ablations and focal electrophysiological oriented ablations in people with Atrial Fibrillation, 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 6 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 29 May 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Heidi Estner, MD (0049 89 1218 2020, estner@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sinus rhythm in follow-up (time frame: Sinus rhythm in follow-up). 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 29 May 2009.