Structural Heart DiseaseOpto-DeEPNCT06937983
Optimised Decrement Evoked Potential (DeEP) Mapping to Guide Ventricular Tachycardia (VT) Ablation in Patients With Structural Heart Disease VT
A study testing Optimised DeEP-guided ablation in people with Structural Heart Disease, run by University Hospitals Coventry and Warwickshire NHS Trust at 1 site in United Kingdom.
Trial summary
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder. Special pacemakers called implantable cardiac defibrillators (ICDs) help treat VT episodes, however they do not prevent the VT episodes from occurring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural Heart Disease
- What is being tested?
- Optimised DeEP-guided ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2025to 3 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- ≥18 years old
- Patients with cardiac implantable electronic devices (CIED) (e.g. pacemakers, cardiac resynchronisation therapy (CRT) devices, implantable cardioverter defibrillator (ICD) devices)
- Eligible for VT ablation as part of standard care (urgent or elective)
- Ischaemic heart disease and prior myocardial infarction (MI) (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) OR other structural heart disease (such as: arrhythmogenic cardiomyopathy (ACM), or dilated cardiomyopathy (DCM), or hypertrophic cardiomyopathy (HCM), or sarcoidosis, or myocarditis).
- Catheter ablation of VT ablation using Abbott intracardiac mapping catheter and Ensite intracardiac mapping system.
Who cannot join
- Lacks capacity to provide informed consent
- New York Heart Association (NYHA) class IV heart failure
- Life expectancy of less than 12 months
- Implanted with a ventricular assist device
- Presence of mobile intracardiac thrombus
- Reversible cause of VT
Show all 9Show fewer
- Women who are pregnant or nursing
- Both mechanical aortic and mitral valves
- Enrolment in a concurrent interventional clinical study that in the judgement of the investigator would increase risk to the patient or deem the patient inappropriate to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, West Midlands, CV2 2DX
About this study
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder. Special pacemakers called implantable cardiac defibrillators (ICDs) help treat VT episodes, however they do not prevent the VT episodes from occurring. Catheter ablation for VT is a minimally-invasive and established procedure for preventing VT recurrence. This involves placing wires in the heart to find the diseased areas that are responsible for the VT episodes. The diseased areas are shown on computer-generated maps and are later removed via controlled tissue heating (ablation). A major challenge during the VT ablation procedure is locating the diseased area responsible for the VT episodes. Several methods have been described to locate the diseased heart area, however these methods are not always effective.
In this study, we aim to improve the identification of the diseased heart areas responsible for the VT episodes using a novel method. Our research group have developed, tested and peer-reviewed this improved method of locating diseased areas by looking for signals called decrementing evoked potentials (DeEPs). Ablation will target DeEPs shown on the computer-generated maps. We will assess if VT can be triggered at the end of the procedure. Patients will be monitored over 12 months to see if ablation of DeEPs leads to a reduction in VT episodes. We aim to recruit 77 patients with established heart disease of any cause, who have suffered VT episodes with ICDs. Suitable patients will be identified and recruited from inpatient and outpatient settings. A quality-of-life questionnaire will be completed by patients before and after the ablation procedure. The procedure will be performed as routine standard of care, in the cardiac catheter laboratory across multiple recruiting cardiac centres in the UK providing well established VT ablation service.
Overall, this study will contribute towards developing refined VT ablation techniques, aiming to improve patient outcomes.
- Conditions
- Structural Heart Disease
- Being tested
- Optimised DeEP-guided ablation
- Keywords
- Ventricular Tachycardia, Decrementing Evoked Potential mapping, Optimisation parameters, Clinical Applicability
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimised DeEP-guided ablationProcedure or surgery
Optimised decrement evoked potential (DeEP) mapping in VT ablation.
| Study group | Role | What they receive |
|---|---|---|
| Optimised DeEP-guided ablation | Experimental | DeEP mapping in VT ablation. Receives: Procedure: Optimised DeEP-guided ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine acute success rate post Opto-DeEP mapping-guided VT ablation.
Number of patients with non-inducible VT acutely after optimised DeEP map-guided ablation.
Measured: From the start to the end of the VT ablation procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start11 Apr 2025
- Primary completion3 Dec 2027 (estimated)
- Study completion3 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Structural Heart DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06937983
- Sponsor's protocol ID
- TD636723
- Acronym
- Opto-DeEP
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudonymised data will be shared on request to the Sponsor and Chief Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimised Decrement Evoked Potential (DeEP) Mapping to Guide Ventricular Tachycardia (VT) Ablation in Patients With Structural Heart Disease VT
- ClinicalTrials.gov ID
- NCT06937983
- Acronym / sponsor ID
- Opto-DeEP / TD636723
- Conditions
- Structural Heart Disease
- Keywords
- Ventricular Tachycardia, Decrementing Evoked Potential mapping, Optimisation parameters, Clinical Applicability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Study start
- 11 Apr 2025 (actual)
- Primary completion
- 3 Dec 2027 (estimated)
- Study completion
- 3 Dec 2027 (estimated)
- First posted
- 22 Apr 2025 (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.
Ventricular tachycardia (VT) is a life-threatening heart rhythm disorder. Special pacemakers called implantable cardiac defibrillators (ICDs) help treat VT episodes, however they do not prevent the VT episodes from occurring. Catheter ablation for VT is a minimally-invasive and established procedure for preventing VT recurrence. This involves placing wires in the heart to find the diseased areas that are responsible for the VT episodes. The diseased areas are shown on computer-generated maps and are later removed via controlled tissue heating (ablation). A major challenge during the VT ablation procedure is locating the diseased area responsible for the VT episodes. Several methods have been described to locate the diseased heart area, however these methods are not always effective.
In this study, we aim to improve the identification of the diseased heart areas responsible for the VT episodes using a novel method. Our research group have developed, tested and peer-reviewed this improved method of locating diseased areas by looking for signals called decrementing evoked potentials (DeEPs). Ablation will target DeEPs shown on the computer-generated maps. We will assess if VT can be triggered at the end of the procedure. Patients will be monitored over 12 months to see if ablation of DeEPs leads to a reduction in VT episodes. We aim to recruit 77 patients with established heart disease of any cause, who have suffered VT episodes with ICDs. Suitable patients will be identified and recruited from inpatient and outpatient settings. A quality-of-life questionnaire will be completed by patients before and after the ablation procedure. The procedure will be performed as routine standard of care, in the cardiac catheter laboratory across multiple recruiting cardiac centres in the UK providing well established VT ablation service.
Overall, this study will contribute towards developing refined VT ablation techniques, aiming to improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Optimised DeEP-guided ablation | Experimental | Procedure: Optimised DeEP-guided ablationDeEP mapping in VT ablation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years old
- Patients with cardiac implantable electronic devices (CIED) (e.g. pacemakers, cardiac resynchronisation therapy (CRT) devices, implantable cardioverter defibrillator (ICD) devices)
- Eligible for VT ablation as part of standard care (urgent or elective)
- Ischaemic heart disease and prior myocardial infarction (MI) (using the international definition of MI: Q waves or imaging evidence of regional myocardial akinesis/thinning in the absence of a non-ischemic cause with documentation of prior ischaemic injury) OR other structural heart disease (such as: arrhythmogenic cardiomyopathy (ACM), or dilated cardiomyopathy (DCM), or hypertrophic cardiomyopathy (HCM), or sarcoidosis, or myocarditis).
- Catheter ablation of VT ablation using Abbott intracardiac mapping catheter and Ensite intracardiac mapping system.
Key exclusion criteria (9 listed)
- Lacks capacity to provide informed consent
- New York Heart Association (NYHA) class IV heart failure
- Life expectancy of less than 12 months
- Implanted with a ventricular assist device
- Presence of mobile intracardiac thrombus
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 |
|---|---|---|
| Optimised DeEP-guided ablationOptimised decrement evoked potential (DeEP) mapping in VT ablation. | Procedure or surgery | Optimised DeEP-guided ablation |
Primary outcome
To determine acute success rate post Opto-DeEP mapping-guided VT ablation.
Time frame: From the start to the end of the VT ablation procedure.
Number of patients with non-inducible VT acutely after optimised DeEP map-guided ablation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. Pseudonymised data will be shared on request to the Sponsor and Chief Investigator.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimised DeEP-guided ablation in people with Structural Heart Disease, run by University Hospitals Coventry and Warwickshire 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 5 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shivam Joshi (+442476966907, optodeepstudyoffice@uhcw.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine acute success rate post Opto-DeEP mapping-guided VT ablation. (time frame: From the start to the end of the VT ablation procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2026.