The RIPPLE AT-PLUS Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-16

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Atrial Tachycardia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Isthmus targeted approach using Ripple Mapping

Intervention: Isthmus targeted approach using Ripple Mapping catheter ablation of atrial tachycardia.

Group Type ACTIVE_COMPARATOR

Catheter ablation of atrial tachycardia: Ripple Mapping guided.

Intervention Type PROCEDURE

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 Mapping

Intervention: conventional catheter ablation of atrial tachycardia.

Group Type ACTIVE_COMPARATOR

Catheter ablation of atrial tachycardia: Conventional mapping guided.

Intervention Type PROCEDURE

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.

Interventions

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Catheter ablation of atrial tachycardia: Ripple Mapping guided.

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.

Intervention Type PROCEDURE

Catheter ablation of atrial tachycardia: Conventional mapping guided.

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Referred for catheter ablation of AT by the direct care team, based on clinical indication.
2. Male or female, aged \>18 years old.
3. Able to consent for recruitment to the trial and the catheter ablation procedure.