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

Primary Purpose

Atrial Tachycardia, Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
AT case 1.1
AT case 2.1
AT case 1.2
AT case 1.3
AT case 1.4
AT case 2.2
AT case 2.3
AT case 2.4
SR Case 1
SR Case 2
Sponsored by
AZ Sint-Jan AV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department Clinical Trial Cardiology
  • Hôpital Cardiologique d Haut Leveque
  • CHU Toulouse
  • Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
  • Deutsches Herzzentrum München
  • St Thomas Hospital London

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Conventional

Non inducibility

Arm 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.

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) .

Outcomes

Primary Outcome Measures

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.
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 Outcome Measures

The number of non-inducible ATPAFA during a redo procedure
Incidence of repeat procedures
Incidence of procedure related complications
Procedure time
Fluoroscopy duration
Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure
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)

Full Information

First Posted
November 8, 2017
Last Updated
August 2, 2022
Sponsor
AZ Sint-Jan AV
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1. Study Identification

Unique Protocol Identification Number
NCT03343860
Brief Title
Catheter Ablation of All Inducible AT Post AF Ablation
Acronym
INDUCATH
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AZ Sint-Jan AV

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Tachycardia, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional
Arm Type
Active Comparator
Arm 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.
Arm Title
Non inducibility
Arm Type
Active Comparator
Arm 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) .
Intervention Type
Procedure
Intervention Name(s)
AT case 1.1
Intervention Description
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
Intervention Name(s)
AT case 2.1
Intervention Description
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
Intervention Name(s)
AT case 1.2
Intervention Description
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
Intervention Name(s)
AT case 1.3
Intervention Description
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
Intervention Name(s)
AT case 1.4
Intervention Description
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
Intervention Name(s)
AT case 2.2
Intervention Description
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
Intervention Name(s)
AT case 2.3
Intervention Description
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
Intervention Name(s)
AT case 2.4
Intervention Description
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
Intervention Name(s)
SR Case 1
Intervention Description
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
Intervention Name(s)
SR Case 2
Intervention Description
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 Outcome Measure Information:
Title
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.
Description
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.
Time Frame
During 12 months follow-up
Secondary Outcome Measure Information:
Title
The number of non-inducible ATPAFA during a redo procedure
Time Frame
At repeat procedure(s) during the 12 months follow-up
Title
Incidence of repeat procedures
Time Frame
During 12 months follow-up
Title
Incidence of procedure related complications
Time Frame
During 12 months follow-up
Title
Procedure time
Time Frame
Baseline
Title
Fluoroscopy duration
Time Frame
Baseline
Title
Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure
Description
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)
Time Frame
At repeat procedure(s) during the 12 months follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastien Knecht, MD, PhD
Organizational Affiliation
sebastien.knecht@azsintjan.be
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department Clinical Trial Cardiology
City
Bruges
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Hôpital Cardiologique d Haut Leveque
City
Bordeaux
ZIP/Postal Code
33304
Country
France
Facility Name
CHU Toulouse
City
Toulouse
Country
France
Facility Name
Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
City
Mainz
Country
Germany
Facility Name
Deutsches Herzzentrum München
City
Munich
ZIP/Postal Code
55131
Country
Germany
Facility Name
St Thomas Hospital London
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Catheter Ablation of All Inducible AT Post AF Ablation

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