The TRAMPOLINE VT Study
Primary Purpose
Ventricular Tachycardia
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Octaray catheter
Standard of care
Sponsored by
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Octaray
Eligibility Criteria
Inclusion Criteria:
- ICD in situ
- Clinical indication for VT ablation; incessant VT or receiving appropriate ICD therapies for VT despite anti-arrhythmic drugs
- Ischaemic or non-ischaemic heart disease
Exclusion Criteria:
- Valvular heart disease precluding LV access
- Cardiotomy within previous 3 months
- Acute coronary syndrome within 6 weeks
- Dialysis patients
- Coagulopathy/Thrombocytopaenia
- Pregnancy/breastfeeding women
- CMR contraindicated
- Prognosis <12 months
- Unable to provide informed consent
Sites / Locations
- St. Bartholomew's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Octaray catheter
Standard of care
Arm Description
VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data.
Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone.
Outcomes
Primary Outcome Measures
Correct identification of VT exit site
The site of VT origin suggested by activation mapping will be confirmed by either:
i) Termination with ablation at this site ii) Entrainment of the tachycardia at this site (concealed fusion with PPI-TCL <30ms and equivalent stimulus-QRS interval to EGM-QRS (30-70% TCL) interval) iii) Pace-mapping (average correlation coefficient >90%)
Completeness of diastolic pathway recording
The VT diastolic interval will be divided into temporal segments:
i) First third: VT entrance ii) Middle third: VT isthmus iii) Final third: VT exit
Completeness of diastolic pathway recording will be assessed according to the number of segments in which electrical activity is recorded
Secondary Outcome Measures
Requirement for ICD therapies at 1 year
ICD devices will be interrogated at 3 and 12 months post ablation, or according to clinical need, and the requirement for appropriate anti-tachycardia pacing (ATP) or defibrillation recorded
VT burden
ICD devices will be interrogated at 3 and 12 months post ablation, or according to clinical need, and the number and duration of recorded VT episodes noted
Symptoms related to arrhythmia
The Arrhythmia-specific questionnaire in Tachycardia and Arrhythmia (ASTA) will be completed both before and 12 months following ablation to assess for quantitative change in arrhythmia-related symptomatology
Morphological changes on serial cardiac MRIs
Cardiac MRI (CMR) will be performed before and 3 months post ablation. Changes in functional, volumetric and scar-related data will be recorded
Full Information
NCT ID
NCT05152784
First Posted
November 24, 2021
Last Updated
November 24, 2022
Sponsor
Barts & The London NHS Trust
Collaborators
Biosense Webster, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05152784
Brief Title
The TRAMPOLINE VT Study
Official Title
Trial of Rapid Activation MaPping Using a nOveL Catheter and Integrated Non-invasivE Imaging in Ventricular Tachycardia
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
April 3, 2024 (Anticipated)
Study Completion Date
October 3, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barts & The London NHS Trust
Collaborators
Biosense Webster, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray catheter and the CARTO3 electro-anatomical mapping system. Procedures will integrate data from cardiac MRI and voltage mapping to identify sites of interest for focussed activation mapping; the investigators hypothesise that the examination of these data will identify critical target sites for ablation. Intra-procedural diagnostic performance of the Octaray will be assessed as the primary outcome, and will be compared with the standard of care. Secondary, clinical outcomes - primarily the need for ICD therapies at 12 months post ablation - will be compared with propensity-matched controls undergoing substrate-based ablation alone.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Octaray
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Propensity-matched cohort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Octaray catheter
Arm Type
Experimental
Arm Description
VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data.
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone.
Intervention Type
Device
Intervention Name(s)
Octaray catheter
Intervention Description
A high density diagnostic catheter used for substrate and activation mapping.
Intervention Type
Device
Intervention Name(s)
Standard of care
Intervention Description
VT ablation guided by substrate-mapping alone.
Primary Outcome Measure Information:
Title
Correct identification of VT exit site
Description
The site of VT origin suggested by activation mapping will be confirmed by either:
i) Termination with ablation at this site ii) Entrainment of the tachycardia at this site (concealed fusion with PPI-TCL <30ms and equivalent stimulus-QRS interval to EGM-QRS (30-70% TCL) interval) iii) Pace-mapping (average correlation coefficient >90%)
Time Frame
Intra-procedural
Title
Completeness of diastolic pathway recording
Description
The VT diastolic interval will be divided into temporal segments:
i) First third: VT entrance ii) Middle third: VT isthmus iii) Final third: VT exit
Completeness of diastolic pathway recording will be assessed according to the number of segments in which electrical activity is recorded
Time Frame
Intra-procedural
Secondary Outcome Measure Information:
Title
Requirement for ICD therapies at 1 year
Description
ICD devices will be interrogated at 3 and 12 months post ablation, or according to clinical need, and the requirement for appropriate anti-tachycardia pacing (ATP) or defibrillation recorded
Time Frame
12 months following VT ablation
Title
VT burden
Description
ICD devices will be interrogated at 3 and 12 months post ablation, or according to clinical need, and the number and duration of recorded VT episodes noted
Time Frame
12 months following VT ablation
Title
Symptoms related to arrhythmia
Description
The Arrhythmia-specific questionnaire in Tachycardia and Arrhythmia (ASTA) will be completed both before and 12 months following ablation to assess for quantitative change in arrhythmia-related symptomatology
Time Frame
12 months following VT ablation
Title
Morphological changes on serial cardiac MRIs
Description
Cardiac MRI (CMR) will be performed before and 3 months post ablation. Changes in functional, volumetric and scar-related data will be recorded
Time Frame
3 months following VT ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ICD in situ
Clinical indication for VT ablation; incessant VT or receiving appropriate ICD therapies for VT despite anti-arrhythmic drugs
Ischaemic or non-ischaemic heart disease
Exclusion Criteria:
Valvular heart disease precluding LV access
Cardiotomy within previous 3 months
Acute coronary syndrome within 6 weeks
Dialysis patients
Coagulopathy/Thrombocytopaenia
Pregnancy/breastfeeding women
CMR contraindicated
Prognosis <12 months
Unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pier D Lambiase, MBBS
Phone
02073 777000
Email
p.lambiase@ucl.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Edd Maclean, MBBS
Email
edd.maclean@qmul.ac.uk
Facility Information:
Facility Name
St. Bartholomew's Hospital
City
London
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edd Maclean, MBBS
Email
edd.maclean@qmul.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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The TRAMPOLINE VT Study
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