Ventricular TachycardiaDTinVTNCT06028919
Power Versus Temperature Controlled Ablation for Treatment of VT
A study testing Tacticath/Tactiflex (TF) ablation catheter in people with Ventricular Tachycardia, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites in United Kingdom.
Trial summary
Ventricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death. The majority of patients that are at risk of VT or suffer a cardiac arrest will have an Internal Cardiac Defibrillator (ICD) in situ to treat… 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?
- Tacticath/Tactiflex (TF) ablation catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 26 Sep 2022to 21 Nov 2025
- 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
- ≥ 18 years of age to give informed consent specific to national legal requirements.
- Subject with 1 of the following:
- Symptomatic VT (despite optimal medical therapy), 3 or more episodes of VT within 24 h (VT storm).
- At least 3 episodes of VT requiring anti-tachycardia pacing (ATP)
- At least one appropriate ICD shock.
- Referred for VT ablation by Consultant Electrophysiologist
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- Subject discussed at cardiac EP MDT
- Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
- Subject agrees to comply with study procedures and be available for routine follow up visits for at least 12 months after enrolment.
- Subject is willing and able to provide written consent
Who cannot join
- BMI >40kg/m2
- Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
- Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
- Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- Renal failure requiring dialysis or renal compromise that in the investigators judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.
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- Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that can't be adequately pre-treated prior to the ablation procedure.
- Positive pregnancy test results for female subjects of childbearing or potential or breast feeding.
- Enrolment in a concurrent clinical study that in the judgement of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.
- Significant GI bleed.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospitals Sussex NHS Foundation Trust
Brighton, BN2 1ES
University Hospital Coventry and Warwickshire NHS Trust
Coventry, West Midlands, CV22DX
About this study
Official title: A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)
Ventricular Tachycardia (VT) is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death.
The majority of patients that are at risk of VT or suffer a cardiac arrest will have an Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can deliver a painful shock to restore normal heart rhythm but importantly does not treat the underlying cause. Current treatment for the prevention of recurrent VT include catheter ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates with CA are around 50%.
The trial is to compare 2 different types of ablation catheter that are used to cauterise small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will provide comparable efficacy and safety for the treatment of VT as the current industry gold standard (TF).
Read the detailed description
This trial compares 2 different types of ablation catheter for the treatment of ventricular tachycardia (VT). VT is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is associated with poor patient prognosis, outcomes and is a leading cause of sudden cardiac death in developed countries.
Current treatments for VT include catheter ablation (CA), medication and having an internal cardiac defibrillator (ICD) implanted, each treatment has advantages and disadvantages. The ICD can deliver a lifesaving shock but this doesn't treat the cause of the VT and can be very painful and upsetting for the patient. Medications can reduce the amount and rate of VT but can have dangerous side effects.
CA involves small tubes being placed in the heart and small areas of unhealthy heart tissue are burnt (ablated) to stop the VT. This is the only treatment that treats the underlying cause but long-term success is about 50% after 1 year.
The investigators want to improve the success rates of VT ablation. There is a new ablation catheter called Diamond Temp which works differently to the current industry gold standard (Tacticath/Tactiflex Catheter). The investigators think the Diamond Temp catheter will be better than the Tacticath catheter but need to do this trial to prove it.
This trial will be at University Hospital Coventry and Warwickshire and University Hospitals Sussex involving patients that suffer VT, have an ICD and need an ablation. If a patient wishes to participate they will give consent and be chosen at random to receive ablation with either Diamond temp or Tacticath/Tactiflex. All other treatment will be the same as after a normal ablation procedure. Participants will be followed up at 6 months and 1 year after the procedure as well as being monitored by the ICD clinic. The study will have 54 patients and be completed in 2025.
- Conditions
- Ventricular Tachycardia
- Being tested
- Temperature controlled DiamondTemp (DT) ablation catheter, Tacticath/Tactiflex (TF) ablation catheter
- Keywords
- temperature controlled irrigated radiofrequency ablation, ventricular tachycardia, clinical outcomes
- Medical subject headings
- Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temperature controlled DiamondTemp (DT) ablation catheterDevice
The DiamondTemp catheter is a new ablation catheter that uses 6 industrial grade diamonds to actually measure the temperature of the surface tissue being cauterised. This enables the DiamondTemp catheter to control the amount of power being delivered from the ablation catheter into the tissue being ablated by maintaining a constant temperature at the surface of the heart.
Tacticath/Tactiflex (TF) ablation catheterDevice
The Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation.
| Study group | Role | What they receive |
|---|---|---|
| Temperature controlled DiamondTemp (DT) ablation catheter | Other | Intervention arm Receives: Device: Temperature controlled DiamondTemp (DT) ablation catheter |
| Power controlled Tacticath/Tactiflex ablation catheter | Other | Control arm Receives: Device: Tacticath/Tactiflex (TF) ablation catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT
The efficacy of each ablation catheter will be compared by measuring the VT burden 12 months post-ablation.
Measured: 12 months post ablation
Assessing the safety of the DT versus the TF ablation catheter for the treatment of VT
The efficacy of each ablation catheter will be compared by measuring the freedom from a composite of pre-specified procedure-related complications (adverse outcomes).
Measured: within 30 days or 6 months after index ablation procedure
Secondary outcomes (1)
Perceived health benefit of treatment
The patient's health benefit will be measured using a EQ-5D-5L questionnaire.
Measured: at baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start26 Sep 2022
- Primary completion21 Nov 2025
- Study completion21 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- patient-blinded, prospective, multi centre, two-arm, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic, Coventry University
- Responsible party
- Sponsor
- Investigators
- Tarv Dhanjal, PhD, Principal investigator, University Hospitals Coventry and Warwickshire NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028919
- Sponsor's protocol ID
- TS584122
- Acronym
- DTinVT
- Status last verified
- Feb 2026
- First submitted
- 31 Aug 2023
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)
- ClinicalTrials.gov ID
- NCT06028919
- Acronym / sponsor ID
- DTinVT / TS584122
- Conditions
- Ventricular Tachycardia
- Keywords
- temperature controlled irrigated radiofrequency ablation, ventricular tachycardia, clinical outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospitals Coventry and Warwickshire NHS TrustUniversity, hospital or other
- Collaborators
- Medtronic, Coventry University
- Study start
- 26 Sep 2022 (actual)
- Primary completion
- 21 Nov 2025 (actual)
- Study completion
- 21 Nov 2025 (actual)
- First posted
- 8 Sep 2023 (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 that comes from the bottom chambers of the heart (the ventricles) and is a leading cause of sudden cardiac death.
The majority of patients that are at risk of VT or suffer a cardiac arrest will have an Internal Cardiac Defibrillator (ICD) in situ to treat the abnormal heart rhythm. The ICD can deliver a painful shock to restore normal heart rhythm but importantly does not treat the underlying cause. Current treatment for the prevention of recurrent VT include catheter ablation (CA) or medication. Long-term results with global 12 month VT-free survival rates with CA are around 50%.
The trial is to compare 2 different types of ablation catheter that are used to cauterise small areas of unhealthy tissue within the heart that are responsible for VT: Diamond Temp (DT) and Tacticath/Tactiflex (TF). Our hypothesis is that the DT ablation catheter will provide comparable efficacy and safety for the treatment of VT as the current industry gold standard (TF).
Detailed description
This trial compares 2 different types of ablation catheter for the treatment of ventricular tachycardia (VT). VT is a life threatening heart rhythm that comes from the bottom chambers of the heart (the ventricles) and is associated with poor patient prognosis, outcomes and is a leading cause of sudden cardiac death in developed countries.
Current treatments for VT include catheter ablation (CA), medication and having an internal cardiac defibrillator (ICD) implanted, each treatment has advantages and disadvantages. The ICD can deliver a lifesaving shock but this doesn't treat the cause of the VT and can be very painful and upsetting for the patient. Medications can reduce the amount and rate of VT but can have dangerous side effects.
CA involves small tubes being placed in the heart and small areas of unhealthy heart tissue are burnt (ablated) to stop the VT. This is the only treatment that treats the underlying cause but long-term success is about 50% after 1 year.
The investigators want to improve the success rates of VT ablation. There is a new ablation catheter called Diamond Temp which works differently to the current industry gold standard (Tacticath/Tactiflex Catheter). The investigators think the Diamond Temp catheter will be better than the Tacticath catheter but need to do this trial to prove it.
This trial will be at University Hospital Coventry and Warwickshire and University Hospitals Sussex involving patients that suffer VT, have an ICD and need an ablation. If a patient wishes to participate they will give consent and be chosen at random to receive ablation with either Diamond temp or Tacticath/Tactiflex. All other treatment will be the same as after a normal ablation procedure. Participants will be followed up at 6 months and 1 year after the procedure as well as being monitored by the ICD clinic. The study will have 54 patients and be completed in 2025.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- patient-blinded, prospective, multi centre, two-arm, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Temperature controlled DiamondTemp (DT) ablation catheter | Other | Device: Temperature controlled DiamondTemp (DT) ablation catheterIntervention arm |
| Power controlled Tacticath/Tactiflex ablation catheter | Other | Device: Tacticath/Tactiflex (TF) ablation catheterControl arm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥ 18 years of age to give informed consent specific to national legal requirements.
- Subject with 1 of the following:
- Referred for VT ablation by Consultant Electrophysiologist
- Subject discussed at cardiac EP MDT
- Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
Key exclusion criteria (10 listed)
- BMI >40kg/m2
- Presence of intramural thrombus, tumour or abnormality that precludes vascular access, catheter introduction or manipulations.
- Coagulopathy, bleeding diathesis or suspected pro-coagulant state.
- Sepsis, active systemic infection or fever (>100.5 F/38 C) within a week prior to the ablation procedure.
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
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 |
|---|---|---|
| Temperature controlled DiamondTemp (DT) ablation catheterThe DiamondTemp catheter is a new ablation catheter that uses 6 industrial grade diamonds to actually measure the temperature of the surface tissue being cauterised. This enables the DiamondTemp catheter to control the amount of power being delivered from the ablation catheter into the tissue being ablated by maintaining a constant temperature at the surface of the heart. | Device | Temperature controlled DiamondTemp (DT) ablation catheter |
| Tacticath/Tactiflex (TF) ablation catheterThe Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation. | Device | Power controlled Tacticath/Tactiflex ablation catheter |
Primary outcome
Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT
Time frame: 12 months post ablation
The efficacy of each ablation catheter will be compared by measuring the VT burden 12 months post-ablation.
Assessing the safety of the DT versus the TF ablation catheter for the treatment of VT
Time frame: within 30 days or 6 months after index ablation procedure
The efficacy of each ablation catheter will be compared by measuring the freedom from a composite of pre-specified procedure-related complications (adverse outcomes).
1 secondary outcome
Perceived health benefit of treatment
Time frame: at baseline and 12 months
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 14 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made available to other researchers.
Related trials for Ventricular Tachycardia
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
RecruitingObservational study
Genetic Markers of Cardiovascular Disease in Epilepsy
Epilepsy, Seizures
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
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.
Tarv Dhanjal, PhD principal investigator
University Hospitals Coventry and Warwickshire NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tacticath/Tactiflex (TF) ablation catheter in people with Ventricular Tachycardia, run by University Hospitals Coventry and Warwickshire NHS Trust at 2 sites 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 10 inclusion and 10 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 14 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 2 sites 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?
Assessing the efficacy of the DT versus the TF ablation catheter for the treatment of VT (time frame: 12 months post ablation). 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?
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 14 Apr 2026.