Catheter Ablation of All Inducible AT Post AF Ablation (INDUCATH)

AZ Sint-Jan AV

Status: Completed

Conditions: Atrial Tachycardia; Atrial Fibrillation

Treatments: Procedure: AT case 2.1; Procedure: AT case 1.1; Procedure: SR Case 1; Procedure: AT case 1.2; Procedure: AT case 2.3; Procedure: AT case 1.3; Procedure: SR Case 2; Procedure: AT case 1.4; Procedure: AT case 2.4; Procedure: AT case 2.2

Study type: Interventional

Funder types: Other

Identifiers

NCT03343860

2097

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Conventional

Active Comparator group

Description:

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.

Treatment:

Procedure: AT case 1.4

Procedure: AT case 1.1

Procedure: AT case 1.3

Procedure: AT case 1.2

Procedure: SR Case 1

Non inducibility

Active Comparator group

Description:

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) .

Treatment:

Procedure: AT case 2.4

Procedure: AT case 2.2

Procedure: SR Case 2

Procedure: AT case 2.1

Procedure: AT case 2.3