The RIPPLE AT-PLUS Study
Isthmus Guided vs Anatomical Linear Ablation in the Treatment of Scar Related Atrial Tachycardia
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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London, United Kingdom, W12 0HS
- Imperial College Healthcare NHS Trust
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London, United Kingdom, L14 3PE
- Liverpool Heart & Chest Hospital
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Newcastle, United Kingdom, NE7 7DN
- Freeman Hospital, The Newcastle Upon Tyne NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Referred for catheter ablation of AT by the direct care team, based on clinical indication.
- Male or female, aged >18 years old.
- Able to consent for recruitment to the trial and the catheter ablation procedure.
Exclusion Criteria:
- Contraindication to catheter ablation as deemed by the clinical team.
- Typical atrial flutter or AF on ECG.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Isthmus targeted approach using Ripple Mapping
Intervention: Isthmus targeted approach using Ripple Mapping catheter ablation of atrial tachycardia.
|
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.
|
|
Active Comparator: Conventional Mapping
Intervention: conventional catheter ablation of atrial tachycardia.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Atrial arrhythmia recurrence
Time Frame: 12 months
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Any confirmed episode of atrial arrhythmia (>30 seconds on Holter or 12 lead ECG) occurring in the 12 months after catheter ablation.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute success during the catheter ablation procedure by the first ablation set.
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).
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Procedure.
|
|
Acute success during the catheter ablation procedure without the need of entrainment.
Time Frame: Procedure.
|
Entrainment not required to confirm or exclude the diagnosis made by 3D electroanatomic mapping methods.
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Procedure.
|
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Procedure failure.
Time Frame: Procedure.
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Inability to terminate atrial tachycardia during the catheter ablation procedure, requiring external electrical cardioversion to achieve sinus rhythm.
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Procedure.
|
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Total procedure time.
Time Frame: Procedure.
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Procedure time measured from initiation of intracardiac mapping to catheter removal from the body.
|
Procedure.
|
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Ablation required
Time Frame: Procedure.
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Ablation required, measured using pre-defined ablation index or ablation line length.
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Procedure.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Vishal Luther, MBBS, Liverpool Heart & Chest Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19SM5013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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