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Power Versus Temperature Controlled Ablation for Treatment of VT

NCT06028919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2026-04-14

No results posted yet for this study

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

Interventions

DEVICE

Temperature controlled DiamondTemp (DT) ablation catheter

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.

DEVICE

Tacticath/Tactiflex (TF) ablation catheter

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

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Coventry University

    collaborator OTHER

  • University Hospitals Coventry and Warwickshire NHS Trust

    lead OTHER

Principal Investigators

  • Tarv Dhanjal, PhD · University Hospitals Coventry and Warwickshire NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-26
Primary Completion
2025-11-21
Completion
2025-11-21

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06028919 on ClinicalTrials.gov