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In the treatment of symptomatic drug resistant persistent atrial fibrillation (Ps AF), catheter ablation has a class IIA indication. During the follow-up, a significant amount of patients (~50%) will experience atrial tachycardias (AT) recurrence. The endpoint of AT ablation during the second procedure has not been validated. At present, several strategies are considered as good clinical practice.
Main objective: To evaluate if ablation of all inducible AT post AF ablation (ATPAFA) offers as substantial benefit in comparison with ablation of the clinical ATPAF only during a redo procedure post initial persistent AF ablation.
Secondary objectives:
To evaluate the prognosis of non-inducibility during a redo procedure for ATPAFA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Active Comparator | PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. |
|
| Non inducibility | Active Comparator | PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AT case 1.1 | Procedure | In the case of AT at the time of ablation : In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from any documented episode of AT or AF lasting longer than 30 seconds without AAD and occurring during the 1 year follow-up after the ATPAF ablation procedure. | There will be a 1-months blanking period after ATPAF ablation. A repeated left atrial ablation at any time (even during the blanking period) will be considered as a recurrence. | During 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The number of non-inducible ATPAFA during a redo procedure | At repeat procedure(s) during the 12 months follow-up | |
| Incidence of repeat procedures | During 12 months follow-up | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastien Knecht, MD, PhD | sebastien.knecht@azsintjan.be | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department Clinical Trial Cardiology | Bruges | 8000 | Belgium | |||
| Hôpital Cardiologique d Haut Leveque |
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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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|
| AT case 2.1 | Procedure | In the case of AT at the time of ablation : In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) |
|
| AT case 1.2 | Procedure | In the case of AT at the time of ablation : In the case of termination to another AT, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. |
|
| AT case 1.3 | Procedure | In the case of AT at the time of ablation : In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps |
|
| AT case 1.4 | Procedure | In the case of AT at the time of ablation : In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. |
|
| AT case 2.2 | Procedure | In the case of AT at the time of ablation : In the case of termination to another AT, ablation of the subsequent AT will be performed until sinus rhythm restoration. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) |
|
| AT case 2.3 | Procedure | In the case of AT at the time of ablation : In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) |
|
| AT case 2.4 | Procedure | In the case of AT at the time of ablation : In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT) |
|
| SR Case 1 | Procedure | In the case of SR at the time of ablation: PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps. |
|
| SR Case 2 | Procedure | In the case of SR at the time of ablation: PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 10 consecutive AT) |
|
| Incidence of procedure related complications |
| During 12 months follow-up |
| Procedure time | Baseline |
| Fluoroscopy duration | Baseline |
| Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure | To evaluate the correlation between the ATPAFA mechanism during the index procedure with potential AT mechanism during the follow up (in the case of AT recurrence) | At repeat procedure(s) during the 12 months follow-up |
| Bordeaux |
| 33304 |
| France |
| CHU Toulouse | Toulouse | France |
| Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz | Mainz | Germany |
| Deutsches Herzzentrum München | Munich | 55131 | Germany |
| St Thomas Hospital London | London | United Kingdom |
| D013568 |
| Pathological Conditions, Signs and Symptoms |