Catheter Ablation of All Inducible AT Post AF Ablation
- Conditions
- Atrial TachycardiaAtrial Fibrillation
- Interventions
- Procedure: AT case 1.1Procedure: AT case 2.1Procedure: AT case 2.2Procedure: AT case 1.2Procedure: AT case 2.3Procedure: AT case 1.3Procedure: AT case 1.4Procedure: AT case 2.4Procedure: SR Case 1Procedure: SR Case 2
- Registration Number
- NCT03343860
- Lead Sponsor
- AZ Sint-Jan AV
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Male or Female Adults (≥18 years old)
- Patients with stable ATPAF at least two months after the first AF ablation procedure.
- Consent signed by the patient after reading the information leaflet
- Mental or physical inability to take part in the study
- Spontaneous AF in the EP lab
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA or coronary artery stenting within the last 3 months
- Unstable angina
- Any cardiac surgery within the last 3 months
- NYHA class III or IV congestive heart failure
- Uncontrolled hyperthyroidism
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional AT case 1.1 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 AT case 2.3 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) . Conventional AT case 1.4 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 AT case 2.1 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) . Non inducibility AT case 2.2 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) . Conventional AT case 1.2 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. Conventional SR Case 1 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 SR Case 2 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) . Conventional AT case 1.3 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 AT case 2.4 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) .
- Primary Outcome Measures
Name Time Method 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. During 12 months follow-up 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.
- Secondary Outcome Measures
Name Time Method Incidence of procedure related complications During 12 months follow-up Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure At repeat procedure(s) during the 12 months follow-up 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)
Incidence of repeat procedures During 12 months follow-up The number of non-inducible ATPAFA during a redo procedure At repeat procedure(s) during the 12 months follow-up Procedure time Baseline Fluoroscopy duration Baseline
Trial Locations
- Locations (6)
Department Clinical Trial Cardiology
🇧🇪Bruges, Belgium
CHU Toulouse
🇫🇷Toulouse, France
Hôpital Cardiologique d Haut Leveque
🇫🇷Bordeaux, France
Deutsches Herzzentrum München
🇩🇪Munich, Germany
Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
🇩🇪Mainz, Germany
St Thomas Hospital London
🇬🇧London, United Kingdom