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| Name | Class |
|---|---|
| Asklepios Klinik St. Georg | UNKNOWN |
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Major objective is to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure.
Underlying hypothesis that in addition, to Re-PVI, an ablation step targeting areas of complex continuous activity will increase atrial arrhythmias freedom compared to Re-PVI only ablation.
Catheter ablation of atrial fibrillation (AF) became first-line therapy in patients not responding to electrical or pharmacological cardioversion. In case of paroxysmal AF, pulmonary vein isolation (PVI) aiming at complete electrical isolation is recommended due to high acute and long term success rates. However, once AF becomes persistent, ablation efficiency dramatically decreases, most likely due to advanced electrical and structural remodeling of the atria.
Some studies, most notably STAR AF II and CHASE AF suggested that additional ablation beyond PVI may not benefit patients as expected. In parallel to studies questioning additional ablation, several studies exploring novel promising techniques were published reporting positive results, e.g. high frequency source ablation, electrogram complexity guided ablation, low voltage amplitude, activation dispersion guided ablation, stepwise ablation approach, autonomic ganglia modification and techniques of identification of rotating waves and point sources to name just few.
Such contrasting studies left EP community confused with regards to the strength of reported claims and practical recommendations. Thus, presently, there is no standard approach to AF substrate ablation and specifics regarding targets and technique are left to physician discretion, most likely resulting in a delivery of unnecessary treatment and obstructing identification of valuable approaches. Thus, there is a need for further studies exploring additional ablation techniques in a rigorous, randomized studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Re-PVI only | Active Comparator | Repeat ablation of pulmonary veins (Re-PVI), followed by electrical cardioversion if AF persists, n=100 pts |
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| Group 2: Re-PVI + substrate ablation | Active Comparator | Repeat ablation of pulmonary veins (Re-PVI) + mapping & ablation of areas of continuous, complex activity, n=100 pts |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Re-PVI only | Procedure | Comparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from atrial arrhythmia | Freedom from any form of sustained atrial arrhythmia (>30 s) follow-up on either a 12 lead ECG on visits or on 48h holter monitoring or on symptom driven event monitoring | through 3 to 12 months |
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Inclusion Criteria:
Patients with persistent atrial fibrillation, defined as atrial fibrillation which is:
Documentation of atrial fibrillation on either a 12-lead ECG or ambulatory holter monitoring or telemetry strip.
One previous PVI only procedure in 3 years previous, but not within the last 3 months.
Age 18 - 80 years.
Patient is willing to participate in the study (signed written informed consent)
Patient is willing and available to perform all follow ups.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vivantes - Klinikum Am Urban | Berlin | 10967 | Germany | |||
| Evangelisches Krankenhaus Duesseldorf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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The study is a prospective, randomized, open-label, blinded endpoint, multi-center study to compare the efficacy of adding additional ablation step (targeting areas of complex, continuous electrical activity in LA) beyond Re-PVI during catheter ablation of Atrial Fibrillation (AF) in patients undergoing 2nd ablation procedure.
Trial flow Patients fitting the enrollment criteria and signing the informed consent form will be included and will undergo the Redo procedure for catheter ablation of pers. AF. After Re-PVI only patients with ongoing or inducted AF will be randomized. Patients, who do not fulfill this intraprocedural criteria for randomization will not be randomized but be treated as dropouts.
Randomization is based on a 1:1 ratio into two study arms:
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| Re-PVI + substrate ablation | Procedure | Comparison of two treatment strategies of persistent AF catheter ablation: Re-PVI vs. Re-PVI + continuous complex activity mapping and ablation. |
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| Düsseldorf |
| 40217 |
| Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| D013568 |
| Pathological Conditions, Signs and Symptoms |