Catheter Ablation of All Inducible AT Post AF Ablation

NCT ID: NCT03343860

Last Updated: 2022-08-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-05
• Study Completion Date: 2022-05-31

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

Conditions

Atrial Tachycardia; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional

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.

Group Type: ACTIVE_COMPARATOR

AT case 1.1

Intervention Type: 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.

AT case 1.2

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

SR Case 1

Intervention Type: 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.

Non inducibility

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) .

Group Type: ACTIVE_COMPARATOR

AT case 2.1

Intervention Type: 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 2.2

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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 2

Intervention Type: 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)

Interventions

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.

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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)

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AZ Sint-Jan AV

OTHER

Sponsor Role: lead

Responsible Party

Sebastien Knecht

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastien Knecht, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

sebastien.knecht@azsintjan.be

Locations

Department Clinical Trial Cardiology

Bruges, , Belgium

Hôpital Cardiologique d Haut Leveque

Bordeaux, , France

CHU Toulouse

Toulouse, , France

Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz

Mainz, , Germany

Deutsches Herzzentrum München

Munich, , Germany

St Thomas Hospital London

London, , United Kingdom

Countries

Belgium; France; Germany; United Kingdom

Other Identifiers

2097

Identifier Type: -

Identifier Source: org_study_id