Catheter Ablation of All Inducible AT Post AF Ablation

NCT03343860 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-08-03

No results posted yet for this study

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

Interventions

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.

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)

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.

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

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.

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)

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)

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)

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.

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)

Sponsors & Collaborators

  • AZ Sint-Jan AV

    lead OTHER

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-05
Primary Completion
2021-03-31
Completion
2022-05-31

Countries

  • Belgium
  • France
  • Germany
  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03343860 on ClinicalTrials.gov