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

August 2, 2022 updated by: Sebastien Knecht, AZ Sint-Jan AV

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruges, Belgium, 8000
        • Department Clinical Trial Cardiology
  • France
      • Bordeaux, France, 33304
        • Hôpital Cardiologique d Haut Leveque
      • Toulouse, France
        • CHU Toulouse
  • Germany
      • Mainz, Germany
        • Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
      • Munich, Germany, 55131
        • Deutsches Herzzentrum München
  • United Kingdom
      • London, United Kingdom
        • St Thomas Hospital London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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 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: 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.
Active Comparator: 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) .
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 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 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During 12 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of non-inducible ATPAFA during a redo procedure
Time Frame: At repeat procedure(s) during the 12 months follow-up
At repeat procedure(s) during the 12 months follow-up
Incidence of repeat procedures
Time Frame: During 12 months follow-up
During 12 months follow-up
Incidence of procedure related complications
Time Frame: During 12 months follow-up
During 12 months follow-up
Procedure time
Time Frame: Baseline
Baseline
Fluoroscopy duration
Time Frame: Baseline
Baseline
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)
At repeat procedure(s) during the 12 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Sebastien Knecht, MD, PhD, sebastien.knecht@azsintjan.be

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2017

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

November 14, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 2, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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