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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ 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

Locations
Other Locations
United Kingdom
University Hospitals Sussex NHS Foundation Trust
RECRUITING
Brighton
University Hospital Coventry and Warwickshire NHS Trust
RECRUITING
Coventry
Contact Information
Primary
Tarv Dhanjal, PhD
Tarv.dhanjal@uhcw.nhs.uk
02476 965668
Backup
Cristiana Huhulea, MSc
Dtinvt@uhcw.nhs.uk
024 7696 7476
Time Frame
Start Date: 2022-09-26
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 64
Treatments
Other: Temperature controlled DiamondTemp (DT) ablation catheter
Intervention arm
Other: Power controlled Tacticath/Tactiflex ablation catheter
Control arm
Sponsors
Collaborators: Coventry University, Medtronic
Leads: University Hospitals Coventry and Warwickshire NHS Trust

This content was sourced from clinicaltrials.gov