Catheter Ablation of All Inducible AT Post AF Ablation
INDUCATH
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
1 other identifier
interventional
60
4 countries
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2017
CompletedFirst Submitted
Initial submission to the registry
November 8, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedAugust 3, 2022
August 1, 2022
4 years
November 8, 2017
August 2, 2022
Conditions
Outcome Measures
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.
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 Outcomes (6)
The number of non-inducible ATPAFA during a redo procedure
At repeat procedure(s) during the 12 months follow-up
Incidence of repeat procedures
During 12 months follow-up
Incidence of procedure related complications
During 12 months follow-up
Procedure time
Baseline
Fluoroscopy duration
Baseline
- +1 more secondary outcomes
Study Arms (2)
Conventional
ACTIVE COMPARATORPV 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.
Non inducibility
ACTIVE COMPARATORPV 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) .
Interventions
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.
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)
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.
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
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.
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)
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)
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)
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.
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AZ Sint-Jan AVlead
Study Sites (6)
Department Clinical Trial Cardiology
Bruges, 8000, Belgium
Hôpital Cardiologique d Haut Leveque
Bordeaux, 33304, France
CHU Toulouse
Toulouse, France
Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
Mainz, Germany
Deutsches Herzzentrum München
Munich, 55131, Germany
St Thomas Hospital London
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sebastien Knecht, MD, PhD
sebastien.knecht@azsintjan.be
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
November 8, 2017
First Posted
November 17, 2017
Study Start
April 5, 2017
Primary Completion
March 31, 2021
Study Completion
May 31, 2022
Last Updated
August 3, 2022
Record last verified: 2022-08