Medical Device Trials
ICTU is also involved in the design and conduct of medical device trials. Current trials include:
Hypothesis: that performing VT ablation using the Hansen Sensei X robotic system early after the first episode of VT after ICD implantation may reduce the number of painful shocks received by the patient and possibly increase life expectancy and quality of life.
Design: Prospective, open, randomised trial. 200 patients from 8 centres in 6 European countries who have experienced their first episode of VT since ICD implantation will be randomised to either robotic VT ablation or standard conventional therapy (ICD reconfiguration) and followed up over 2 years to assess the number of subsequent ICD shocks, hospitalisation, mortality and quality of life.
Hypothesis: A streamlined AF ablation procedure done without PV mapping as a daycase is more effective than anti-arrhythmic drugs at reducing all hospital episodes for recurrent atrial fibrillation.
Design: Multicentre, randomised clinical trial in 300 patients randomised to three arms
Imperial's bioengineering dept works supports hundreds of medical device companies in the design and evaluation of medical devices across a broad spectrum of therapies