Power Versus Temperature Controlled Ablation for Treatment of VT
A Randomised Control Trial of Power Versus Temperature-controlled Irrigated Radiofrequency Ablation for the Treatment of Ventricular Tachycardia (VT)
University Hospitals Coventry and Warwickshire NHS Trust
64 participants
Sep 26, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria10
- ≥ 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 Criteria10
- 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.
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Interventions
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.
The Tactiflex ablation catheter is currently the market leader and routinely used for VT ablation.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT06028919