Comparing two types of ablation catheters for treating ventricular tachycardia
A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)
This study is testing which of two different ablation catheters works better for treating life-threatening heart rhythms in patients who have an internal defibrillator and experience repeated episodes of ventricular tachycardia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospitals Coventry and Warwickshire NHS Trust Academic / other |
| Locations | 2 sites (Coventry, West Midlands and 1 other locations) |
| Trial ID | NCT06028919 on ClinicalTrials.gov |
What this trial studies
This trial compares the efficacy and safety of two different ablation catheters, Diamond Temp (DT) and Tacticath/Tactiflex (TF), for the treatment of ventricular tachycardia (VT), a life-threatening heart rhythm. Patients with an internal cardiac defibrillator (ICD) who experience recurrent VT will be enrolled to assess which catheter provides better outcomes. The study aims to improve the long-term success rates of catheter ablation, which currently stands at about 50% after one year. Participants will be monitored for at least 12 months post-enrollment to evaluate the effectiveness of the treatments.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who experience symptomatic ventricular tachycardia despite optimal medical therapy and have an ICD.
Not a fit: Patients with a BMI over 40 kg/m2 or those with conditions that prevent catheter access will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options and better long-term outcomes for patients suffering from ventricular tachycardia.
How similar studies have performed: While catheter ablation is a standard treatment for VT, the specific comparison of the Diamond Temp and Tacticath catheters is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥ 18 years of age to give informed consent specific to national legal requirements. * Subject with 1 of the following: 1. Symptomatic VT (despite optimal medical therapy), 3 or more episodes of VT within 24 h (VT storm). 2. At least 3 episodes of VT requiring anti-tachycardia pacing (ATP) 3. 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 Exclusion Criteria: * 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.
Where this trial is running
Coventry, West Midlands and 1 other locations
- University Hospital Coventry and Warwickshire NHS Trust — Coventry, West Midlands, United Kingdom (Recruiting)
- University Hospitals Sussex NHS Foundation Trust — Brighton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Tarv Dhanjal, PhD — University Hospitals Coventry and Warwickshire NHS Trust
- Study coordinator: Tarv Dhanjal, PhD
- Email: Tarv.dhanjal@uhcw.nhs.uk
- Phone: 02476 965668
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.