TRACT VT
Research type
Research Study
Full title
A Clinical Evaluation of the DiamondTemp™ System TempeRAture Controlled Ablation for the Treatment of Ventricular Tachycardia.
IRAS ID
308088
Contact name
Sandra Jacobs
Contact email
Sponsor organisation
Medtronic
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Cardiac Ablation therapy is used to treat irregular heart rhythms known as heart arrhythmia, which if located in the ventricle of the heart is known as ventricular tachycardia (VT). Cardiac ablation therapy is established as an acceptable therapy to treat patients with VT when drug therapy has failed. Cardiac ablation offers an option for control of VT with the potential for long-term elimination of VT. Historically, it has been difficult to ablate ischemic VT with non-irrigated ablation technology; this may be due to inadequate lesion size generation.
Ablation systems ablate heart tissue by either heating or freezing the tissue. In recent years, strategies, tools, and techniques have been improving to identify key ablation sites and to deliver effective lesions such as;
- Targeting specific areas known as ‘local abnormal ventricular activities (LAVA)’.
- The use of open-irrigated ablation catheters to produce larger lesions, which also helps reduce the risk of coagulum (clots) and tissue charring due to high temperatures.This study is not an experimental study, the device and procedure will be conducted in line with standard of care, commercial practices.
The TRACT VT study aims to further assess the safety and performance of the Medtronic DiamondTemp Ablation System, in the treatment of VT.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
22/WM/0017
Date of REC Opinion
28 Feb 2022
REC opinion
Further Information Favourable Opinion