Ventricular TachycardiaNCT05152784
The TRAMPOLINE VT Study
A study testing Octaray catheter in people with Ventricular Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia
- What is being tested?
- Octaray catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Nov 2022to 23 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Valvular heart disease precluding LV access
- Cardiotomy within previous 3 months
- Acute coronary syndrome within 6 weeks
- Dialysis patients
- Coagulopathy/Thrombocytopaenia
- Pregnancy/breastfeeding women
Show all 9Show fewer
- CMR contraindicated
- Prognosis <12 months
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial of Rapid Activation MaPping Using a nOveL Catheter and Integrated Non-invasivE Imaging in Ventricular Tachycardia
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT), and extrastimulus voltage mapping will 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 and Optrell catheters 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. Follow-up MRI scans will review the impact of ablation on the elimination of conduction channels.
- Conditions
- Ventricular Tachycardia
- Being tested
- Octaray catheter, Standard of care
- Keywords
- Octaray
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octaray catheterDevice
A high density diagnostic catheter used for substrate and activation mapping.
Standard of careDevice
VT ablation guided by substrate-mapping alone.
| Study group | Role | What they receive |
|---|---|---|
| Octaray catheter | Experimental | VT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data. Receives: Device: Octaray catheter |
| Standard of care | Active comparator | Identified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone. Receives: Device: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct identification of VT exit site
The site of VT origin suggested by activation mapping will be confirmed by either:
- 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%)
Measured: Intra-procedural
Completeness of diastolic pathway recording
The VT diastolic interval will be divided into temporal segments:
- 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
Measured: Intra-procedural
Secondary outcomes (4)
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
Measured: 12 months following VT ablation
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
Measured: 12 months following VT ablation
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
Measured: 12 months following VT ablation
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
Measured: 3 months following VT ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start21 Nov 2022
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Propensity-matched cohort study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152784
- Sponsor's protocol ID
- 293735
- Status last verified
- Mar 2025
- First submitted
- 24 Nov 2021
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Maclean E, Tonko J, Creta A, Jyothish M, Uy C, Sevier L, Whittaker-Axon S, Chow A, Hunter RJ, Schilling RJ, Dhinoja M, Bhuva A, Petersen SE, Manisty C, Srinivasan N, Lambiase PD. MRI-guided multipolar functional substrate mapping identifies intramural conduction corridors: The TRAMPOLINE VT study. Heart Rhythm. 2026 Aug 25:S1547-5271(26)02726-8. doi: 10.1016/j.hrthm.2026.08.025. Online ahead of print.
PubMed 42641842
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Rapid Activation MaPping Using a nOveL Catheter and Integrated Non-invasivE Imaging in Ventricular Tachycardia
- ClinicalTrials.gov ID
- NCT05152784
- Acronym / sponsor ID
- 293735
- Conditions
- Ventricular Tachycardia
- Keywords
- Octaray
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Biosense Webster, Inc.
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-randomised, prospective trial will examine the feasibility and efficacy of VT ablation guided by activation mapping using the Octaray and Optrell catheters. Annotation algorithms within the CARTO3 electro-anatomical mapping system will be integrated with 3D scar segmentation data from cardiac MRI (ADAS-VT), and extrastimulus voltage mapping will 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 and Optrell catheters 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. Follow-up MRI scans will review the impact of ablation on the elimination of conduction channels.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Propensity-matched cohort study
| Arm | Type | Receives |
|---|---|---|
| Octaray catheter | Experimental | Device: Octaray catheterVT ablation guided by activation mapping using the Octaray catheter and integrated cardiac MRI data. |
| Standard of care | Active comparator | Device: Standard of careIdentified retrospectively from registry data: propensity matched-controls undergoing VT ablation guided by substrate-modification alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- Valvular heart disease precluding LV access
- Cardiotomy within previous 3 months
- Acute coronary syndrome within 6 weeks
- Dialysis patients
- Coagulopathy/Thrombocytopaenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octaray catheterA high density diagnostic catheter used for substrate and activation mapping. | Device | Octaray catheter |
| Standard of careVT ablation guided by substrate-mapping alone. | Device | Standard of care |
Primary outcome
Correct identification of VT exit site
Time frame: Intra-procedural
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
Time frame: Intra-procedural
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
4 secondary outcomes
Requirement for ICD therapies at 1 year
Time frame: 12 months following VT ablation
VT burden
Time frame: 12 months following VT ablation
Symptoms related to arrhythmia
Time frame: 12 months following VT ablation
Morphological changes on serial cardiac MRIs
Time frame: 3 months following VT ablation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Derived from this study: PubMed 42641842Maclean E, Tonko J, Creta A, Jyothish M, Uy C, Sevier L, Whittaker-Axon S, Chow A, Hunter RJ, Schilling RJ, Dhinoja M, Bhuva A, Petersen SE, Manisty C, Srinivasan N, Lambiase PD. MRI-guided multipolar functional substrate mapping identifies intramural conduction corridors: The TRAMPOLINE VT study. Heart Rhythm. 2026 Aug 25:S1547-5271(26)02726-8. doi: 10.1016/j.hrthm.2026.08.025. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Octaray catheter in people with Ventricular Tachycardia, run by Barts & The London NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correct identification of VT exit site (time frame: Intra-procedural). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152784, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.