Clinical trial NCT03343860: Catheter Ablation of All Inducible AT Post AF Ablation
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
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Tachycardia
Atrial Fibrillation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: 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.
timeFrame: During 12 months follow-up
Secondary outcomes:
measure: The number of non-inducible ATPAFA during a redo procedure
timeFrame: At repeat procedure(s) during the 12 months follow-up
measure: Incidence of repeat procedures
timeFrame: During 12 months follow-up
measure: Incidence of procedure related complications
timeFrame: During 12 months follow-up
measure: Procedure time
timeFrame: Baseline
measure: Fluoroscopy duration
timeFrame: Baseline
measure: Correlation of the AT mechanism during the redo procedure with the AT Mechanism during the index procedure
timeFrame: At repeat procedure(s) during the 12 months follow-up
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: Department Clinical Trial Cardiology
city: Bordeaux
country: France
facility: Hôpital Cardiologique d Haut Leveque
city: Toulouse
country: France
facility: CHU Toulouse
city: Mainz
country: Germany
facility: Medizinische Klinik und Poliklinik, Universitätsmedizin Mainz
city: Munich
country: Germany
facility: Deutsches Herzzentrum München
city: London
country: United Kingdom
facility: St Thomas Hospital London
Study officials:
affiliation: sebastien.knecht@azsintjan.be
name: Sebastien Knecht, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: