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

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ClinicalTrials.gov Identifier: NCT03343860
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
Sebastien Knecht, AZ Sint-Jan AV

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


Condition or disease Intervention/treatment Phase
Atrial Tachycardia Atrial Fibrillation Procedure: AT case 1.1 Procedure: AT case 2.1 Procedure: AT case 1.2 Procedure: AT case 1.3 Procedure: AT case 1.4 Procedure: AT case 2.2 Procedure: AT case 2.3 Procedure: AT case 2.4 Procedure: SR Case 1 Procedure: SR Case 2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine


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)





Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343860


Contacts
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Contact: Katrien Derycker 0032503896 Katrien.Derycker@azsintjan.be
Contact: Kelly De Jaegher 0032502896 Kelly.DeJaegher@azsintjan.be

Locations
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Belgium
Department Clinical Trial Cardiology Recruiting
Bruges, Belgium, 8000
Contact: Sebastien Knecht, MD, PhD       sebastien.knecht@azsintjan.be   
Principal Investigator: Sebastien Knecht, MD, PhD         
Sub-Investigator: Mattias Duytschaever, MD, PhD         
Sub-Investigator: Rene Tavernier, MD, PhD         
France
Hôpital Cardiologique d Haut Leveque Not yet recruiting
Bordeaux, France, 33304
Contact: Pierre Jais, MD, PhD       Pierre.jais@chu-bordeaux.fr   
Principal Investigator: Pierre Jais, MD, PhD         
CHU Toulouse Not yet recruiting
Toulouse, France
Contact: Philippe Maury, MD         
Principal Investigator: Philippe Maury, MD         
Germany
Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz Recruiting
Mainz, Germany
Contact: Thomas Rostock, MD, PhD       thomas.rostock@unimedizin-mainz.de   
Principal Investigator: Thomas Rostock, MD, PhD         
Deutsches Herzzentrum München Not yet recruiting
Munich, Germany, 55131
Contact: Isabelle Deisenhoffer, MD, PhD       deisenhofer@dhm.mhn.de   
Principal Investigator: Isabelle Deisenhoffer, MD, PhD         
United Kingdom
St Thomas Hospital London Not yet recruiting
London, United Kingdom
Contact: Mark O'Neill, MD, PhD         
Principal Investigator: St Thomas Hospital O'Neill, MD, PhD         
Sponsors and Collaborators
AZ Sint-Jan AV
Investigators
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Principal Investigator: Sebastien Knecht, MD, PhD sebastien.knecht@azsintjan.be

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Responsible Party: Sebastien Knecht, Professor Doctor, AZ Sint-Jan AV
ClinicalTrials.gov Identifier: NCT03343860     History of Changes
Other Study ID Numbers: 2097
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Cardiac Conduction System Disease