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The RIPPLE AT-PLUS Study

Primary Purpose

Atrial Tachycardia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Catheter ablation of atrial tachycardia: Ripple Mapping guided.
Catheter ablation of atrial tachycardia: Conventional mapping guided.
Sponsored by
Liverpool Heart and Chest Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Tachycardia focused on measuring Atrial Tachycardia, Atrial Fibrillation, Mapping, Ablation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

  1. Contraindication to catheter ablation as deemed by the clinical team.
  2. Typical atrial flutter or AF on ECG.

Sites / Locations

  • Liverpool Heart & Chest Hospital
  • Imperial College Healthcare NHS Trust
  • Freeman Hospital, The Newcastle Upon Tyne NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Isthmus targeted approach using Ripple Mapping

Conventional Mapping

Arm Description

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

Intervention: conventional catheter ablation of atrial tachycardia.

Outcomes

Primary Outcome Measures

Atrial arrhythmia recurrence
Any confirmed episode of atrial arrhythmia (>30 seconds on Holter or 12 lead ECG) occurring in the 12 months after catheter ablation.

Secondary Outcome Measures

Acute success during the catheter ablation procedure by the first ablation set.
Atrial tachycardia termination (acute success) during ablation delivered to only target the diagnosed AT mechanism by the mapping approach used (first ablation set).
Acute success during the catheter ablation procedure without the need of entrainment.
Entrainment not required to confirm or exclude the diagnosis made by 3D electroanatomic mapping methods.
Procedure failure.
Inability to terminate atrial tachycardia during the catheter ablation procedure, requiring external electrical cardioversion to achieve sinus rhythm.
Total procedure time.
Procedure time measured from initiation of intracardiac mapping to catheter removal from the body.
Ablation required
Ablation required, measured using pre-defined ablation index or ablation line length.

Full Information

First Posted
April 12, 2019
Last Updated
September 2, 2022
Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust, Imperial College Healthcare NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03915691
Brief Title
The RIPPLE AT-PLUS Study
Official Title
Isthmus Guided vs Anatomical Linear Ablation in the Treatment of Scar Related Atrial Tachycardia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 23, 2022 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborators
Newcastle-upon-Tyne Hospitals NHS Trust, Imperial College Healthcare NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Tachycardia
Keywords
Atrial Tachycardia, Atrial Fibrillation, Mapping, Ablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isthmus targeted approach using Ripple Mapping
Arm Type
Active Comparator
Arm Description
Intervention: Isthmus targeted approach using Ripple Mapping catheter ablation of atrial tachycardia.
Arm Title
Conventional Mapping
Arm Type
Active Comparator
Arm Description
Intervention: conventional catheter ablation of atrial tachycardia.
Intervention Type
Procedure
Intervention Name(s)
Catheter ablation of atrial tachycardia: Ripple Mapping guided.
Intervention Description
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
Intervention Name(s)
Catheter ablation of atrial tachycardia: Conventional mapping guided.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Atrial arrhythmia recurrence
Description
Any confirmed episode of atrial arrhythmia (>30 seconds on Holter or 12 lead ECG) occurring in the 12 months after catheter ablation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Acute success during the catheter ablation procedure by the first ablation set.
Description
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.
Title
Acute success during the catheter ablation procedure without the need of entrainment.
Description
Entrainment not required to confirm or exclude the diagnosis made by 3D electroanatomic mapping methods.
Time Frame
Procedure.
Title
Procedure failure.
Description
Inability to terminate atrial tachycardia during the catheter ablation procedure, requiring external electrical cardioversion to achieve sinus rhythm.
Time Frame
Procedure.
Title
Total procedure time.
Description
Procedure time measured from initiation of intracardiac mapping to catheter removal from the body.
Time Frame
Procedure.
Title
Ablation required
Description
Ablation required, measured using pre-defined ablation index or ablation line length.
Time Frame
Procedure.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Balrik Kailey, MBBS, BA
Phone
+442033133000
Email
bkailey@ic.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Vishal Luther, MBBS
Phone
+442033133000
Email
vishal.luther@lhch.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vishal Luther, MBBS
Organizational Affiliation
Liverpool Heart & Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liverpool Heart & Chest Hospital
City
London
ZIP/Postal Code
L14 3PE
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balrik Kailey, MBBS, BA
Email
b.kailey@ic.ac.uk
First Name & Middle Initial & Last Name & Degree
Vishal Luther, MBBS
Facility Name
Imperial College Healthcare NHS Trust
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Balrik Kailey, MBBS, BA
First Name & Middle Initial & Last Name & Degree
Prapa Kanagaratnam, PhD
Facility Name
Freeman Hospital, The Newcastle Upon Tyne NHS Foundation Trust
City
Newcastle
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruairidh Martin
Email
ruairidh.martin@nuth.nhs.uk

12. IPD Sharing Statement

Plan to Share IPD
No

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The RIPPLE AT-PLUS Study

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