A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (DTinVT)
Ventricular Tachycardia
About this trial
This is an interventional treatment trial for Ventricular Tachycardia focused on measuring temperature controlled irrigated radiofrequency ablation, ventricular tachycardia, clinical outcomes
Eligibility Criteria
Inclusion Criteria: ≥ 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 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.
Sites / Locations
- University Hospital Coventry and Warwickshire NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Other
Other
Temperature controlled DiamondTemp (DT) ablation catheter
Power controlled Tacticath/Tactiflex ablation catheter
Intervention arm
Control arm