Power Versus Temperature Controlled Ablation for Treatment of VT

Launched by UNIVERSITY HOSPITALS COVENTRY AND WARWICKSHIRE NHS TRUST · Aug 31, 2023

Keywords

ClinConnect Summary

This clinical trial is studying two different types of catheter ablation treatments for Ventricular Tachycardia (VT), a serious heart condition that can lead to life-threatening situations. The trial aims to compare the Diamond Temp (DT) catheter and the Tacticath/Tactiflex (TF) catheter to see if the new DT option is just as effective and safe as the current gold standard (TF) for treating VT. Catheter ablation is a procedure that targets and removes unhealthy tissue in the heart that causes these dangerous heart rhythms.

To be eligible for the trial, participants must be at least 18 years old and have experienced significant symptoms of VT despite receiving the best medical treatment. This includes having multiple episodes of VT in a short time or receiving shocks from an Internal Cardiac Defibrillator (ICD). Those who join the study will undergo the ablation procedure and will have regular follow-up visits for at least a year. It’s important to note that certain health conditions, like severe obesity or active infections, may exclude someone from participating. This trial is currently recruiting participants of all genders, aged 18 and older, who meet the criteria.

Gender

ALL

Eligibility 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.