Ablation of Consecutive Atrial Tachycardia

Study Overview
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Brief Summary
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Ablation of consecutive atrial tachycardia (AT) after ablation of atrial fibrillation (AF) or cardiac surgery can be challenging due to complex substrate and AT mechanisms. A substantial portion of patients is known to show various tachycardias and recurrences occur in a noticeable number of cases. With the availability of novel ultra-high-density mapping techniques characterization and understanding of AT mechanisms and underlying substrate can be improved. Aim of this prospective, multi-center, randomized study is to compare a standard AT ablation approach versus minimalized ablation of the clinical AT in regards to arrhythmia free survival.

Official Title
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Ablation of CONseCutive atriaL Tachycardia gUided by Ultra-high-DEnsity Mapping

Conditions
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Heart Arrhythmia, Heart Diseases, Arrhythmias, Cardiac, Atrial Tachycardia

Intervention / Treatment
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* Procedure: Catheter ablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive AT subsequent to prior AF ablation procedure or cardiac surgery Surface ECG-documentation of AT as primary clinical arrhythmia ECG indicating stable, map-able AT (stable activation sequence, and CL stability) with cycle length ≥ 200ms Exclusion Criteria: < 18 years No previous atrial fibrillation ablation procedure or cardiac surgery Pregnant women or women of childbearing potential without a negative pregnancy test within 48 hours prior to treatment History of hemorrhagic diathesis or other coagulopathies Contraindications for oral anticoagulation Hyper- or hypothyroidism Has any condition that would make participation not be in the best interest of the subject

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard approach<br>Patients will receive a standard approach for ablation of atrial tachycardia. | Procedure: Catheter ablation<br>* Catheter-based ablation of arrhythmias using radiofrequency.<br>|
| Experimental: Minimalized approach<br>Patients will receive a minimalized approach for ablation of atrial tachycardia. | Procedure: Catheter ablation<br>* Catheter-based ablation of arrhythmias using radiofrequency.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of any sustained arrhythmia (>30 sec.) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inducibility of atrial tachycardia (AT) after ablation of clinical/primary AT (partial success) | Categorical variable (yes/no) | Intraprocedural | 
| Predictability of secondary AT by analysis of clinical AT map and voltage map |  | Intraprocedural | 
| Procedure duration time |  | Intraprocedural | 
| Fluoroscopy time |  | intraprocedural | 
| Total radiofrequency application time |  | intraprocedural | 
| Ablated area (cm2) |  | intraprocedural | 
| Number of blocked lines |  | intraprocedural | 
| Area of low voltage in sinus map (cm2) |  | Intraprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atrial fibrillation, Atrial tachycardia, Pulmonary vein isolation, Electroanatomical mapping, High density mapping