Status:
RECRUITING
Power Versus Temperature Controlled Ablation for Treatment of VT
Lead Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Collaborating Sponsors:
Medtronic
Coventry University
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 patie...
Detailed Description
This trial compares 2 different types of ablation catheter for the treatment of ventricular tachycardia (VT). VT is a life threatening heart rhythm that comes from the bottom chambers of the heart (th...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
September 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06028919
Start Date
September 26 2022
End Date
March 1 2026
Last Update
September 19 2024
Active Locations (2)
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1
University Hospital Coventry and Warwickshire NHS Trust
Coventry, West Midlands, United Kingdom, CV22DX
2
University Hospitals Sussex NHS Foundation Trust
Brighton, United Kingdom, BN2 1ES