Power Versus Temperature Controlled Ablation for Treatment of VT

NCT06028919 | Completed

• 1 other identifier: TS584122
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 2

Brief 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 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).

Conditions

Ventricular Tachycardia

Keywords

temperature controlled irrigated radiofrequency ablation; ventricular tachycardia; clinical outcomes

Outcome Measures

Primary Outcomes (2)

• 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.

  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).

  within 30 days or 6 months after index ablation procedure

Secondary Outcomes (1)

• Perceived health benefit of treatment

  at baseline and 12 months

Study Arms (2)

Temperature controlled DiamondTemp (DT) ablation catheter

OTHER

Intervention arm

Device: Temperature controlled DiamondTemp (DT) ablation catheter

Power controlled Tacticath/Tactiflex ablation catheter

OTHER

Control arm

Device: Tacticath/Tactiflex (TF) ablation catheter

Interventions

Temperature controlled DiamondTemp (DT) ablation catheter DEVICE

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.

Temperature controlled DiamondTemp (DT) ablation catheter

Tacticath/Tactiflex (TF) ablation catheter DEVICE

The Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation.

Power controlled Tacticath/Tactiflex ablation catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead
• Medtronic: collaborator
• Coventry University: collaborator

Study Sites (2)

University Hospital Coventry and Warwickshire NHS Trust

Coventry, West Midlands, CV22DX, United Kingdom

Location

University Hospitals Sussex NHS Foundation Trust

Brighton, BN2 1ES, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Tarv Dhanjal, PhD

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patient will be blinded to which trial arm they have been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patient-blinded, prospective, multi centre, two-arm, randomised controlled trial

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 8, 2023
• Study Start: September 26, 2022
• Primary Completion: November 21, 2025
• Study Completion: November 21, 2025
• Last Updated: April 14, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)