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Completed

NCT Number: NCT03343860

Catheter Ablation of All Inducible AT Post AF Ablation

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

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Key information

Conditions

Atrial Tachycardia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department Clinical Trial Cardiology, Bruges, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AT case 1.1

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 2.1

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 1.2

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

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

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.

AT case 2.2

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

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

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 1

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.

SR Case 2

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)

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. The number of non-inducible ATPAFA during a redo procedure

    Time frame: At repeat procedure(s) during the 12 months follow-up

  2. Incidence of repeat procedures

    Time frame: During 12 months follow-up

  3. Incidence of procedure related complications

    Time frame: During 12 months follow-up

  4. Procedure time

    Time frame: Baseline

  5. Fluoroscopy duration

    Time frame: Baseline

  6. Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

AZ Sint-Jan AV

Other

Registry information

Official study 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

Acronym: INDUCATH

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Nov 17, 2017
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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