Catheter Ablation of All Inducible AT Post AF Ablation

Atrial Fibrillation Clinical Trial

— INDUCATH  

Official title:

Is Ablation of All Inducible Atrial Tachycardias an Appropriate Endpoint During Redo Procedures After Initial Persistent AF Ablation? A Multi-center, Randomised, Single-blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343860
• Other study ID #: 2097
• Status: Completed
• Phase: N/A
• Start date: April 5, 2017
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2022
• Source: AZ Sint-Jan AV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Tachycardia
• Tachycardia

Intervention

Procedure:
• AT case 1.1
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.
• AT case 2.1
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
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
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
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
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
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
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
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
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)

Locations

Country	Name	City	State
Belgium	Department Clinical Trial Cardiology	Bruges
France	Hôpital Cardiologique d Haut Leveque	Bordeaux
France	CHU Toulouse	Toulouse
Germany	Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz	Mainz
Germany	Deutsches Herzzentrum München	Munich
United Kingdom	St Thomas Hospital London	London

Sponsors (1)

Lead Sponsor	Collaborator
AZ Sint-Jan AV

Countries where clinical trial is conducted

Belgium,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The number of non-inducible ATPAFA during a redo procedure		At repeat procedure(s) during the 12 months follow-up
Secondary	Incidence of repeat procedures		During 12 months follow-up
Secondary	Incidence of procedure related complications		During 12 months follow-up
Secondary	Procedure time		Baseline
Secondary	Fluoroscopy duration		Baseline
Secondary	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