Power Versus Temperature Controlled Ablation for Treatment of VT — DTinVT  

Ventricular Tachycardia Clinical Trial

Official title: A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)

Status Recruiting

Clinical 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 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

• NCT number: NCT06028919
• Study type: Interventional
• Source: University Hospitals Coventry and Warwickshire NHS Trust
• Contact: Tarv Dhanjal, PhD
• Phone: 02476 965668
• Email: Tarv.dhanjal@uhcw.nhs.uk
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Completion date: September 1, 2025