NCT Number: NCT03915691
Atrial tachycardia is a symptomatic arrhythmia, for which an effective treatment is a catheter ablation procedure. The goal of the Ripple AT-Plus study is to evaluate two methods of performing catheter ablation for atrial tachycardia. The main outcome assessed during the study is long-term recurrence of atrial tachycardia following the catheter ablation procedure.
This study is active but is not currently recruiting participants.
18 year–80 year
All sexes
Interventional
Not applicable
Imperial College Healthcare NHS Trust, London, United Kingdom
Catheter based mapping of the electrical signals in the heart during atrial tachycardia can identify areas that require ablation in order to treat the arrhythmia. There are numerous methods by which to map atrial tachycardia. Isthmus guided ablation using Ripple Mapping is one such method, and has recently been demonstrated to improve diagnostic accuracy of mapping and therefore improve acute procedural outcomes (termination of the tachycardia).
However, it is not known if improved acute procedural outcomes translate into long-term benefits for patients. At present, the recurrence rate following atrial tachycardia ablation is near 30%. We hypothesise that isthmus guided ablation using Ripple Mapping can reduce long-term recurrence following ablation as improved diagnostic accuracy of mapping can lead to more targeted, less extensive, ablation.
Patients referred for catheter ablation of atrial tachycardia will be randomised to undergo the procedure by isthmus targeted approach using Ripple Mapping or conventional approach using local activation time. Otherwise, the catheters used to perform the mapping and ablation will be the same in both groups. After the procedure, follow up will occur at 1 year with a further Holter Montior. Any arrhythmia recurrence will be documented and the two arms will be compared for acute success, 12 month success, ablation required and procedure time.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ripple Mapping is used to map the atrial tachycardia mechanism. Using the scar thresholding technique the Ripple Map is interpreted and catheter ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using Ripple Mapping. This can include lesions created at previous ablation procedures.
Conventional activation mapping is used to map the atrial tachycardia mechanism. The resultant (activation) map is interpreted and ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using conventional mapping. This can include lesions created at previous ablation procedures.
Time frame: 12 months
Any confirmed episode of atrial arrhythmia (>30 seconds on Holter or 12 lead ECG) occurring in the 12 months after catheter ablation.
Time frame: Procedure.
Atrial tachycardia termination (acute success) during ablation delivered to only target the diagnosed AT mechanism by the mapping approach used (first ablation set).
Time frame: Procedure.
Entrainment not required to confirm or exclude the diagnosis made by 3D electroanatomic mapping methods.
Time frame: Procedure.
Inability to terminate atrial tachycardia during the catheter ablation procedure, requiring external electrical cardioversion to achieve sinus rhythm.
Time frame: Procedure.
Procedure time measured from initiation of intracardiac mapping to catheter removal from the body.
Time frame: Procedure.
Ablation required, measured using pre-defined ablation index or ablation line length.
Liverpool Heart and Chest Hospital NHS Foundation Trust
Other
Isthmus Guided vs Anatomical Linear Ablation in the Treatment of Scar Related Atrial Tachycardia
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