VIVO mapping Protocol
Research type
Research Study
Full title
VIVO™ non-invasive Time Assessment Protocol
IRAS ID
257755
Contact name
Sabine Ernst
Contact email
Sponsor organisation
Royal Brompton and Harefield NHS Foundation Trust (RB&HFT)
Duration of Study in the UK
0 years, 10 months, 31 days
Research summary
This is a single center study enrolling 15 subjects with structurally normal hearts that are already indicated for a ventricular ablation procedure (VT or PVCs).
The purpose is to compare the accuracy of VIVO and to assess its efficacy to decrease procedural time, and ideally, the procedural overall costs, as compared to standard of care ablation procedures.
Subjects will undergo a CT scan prior to the procedure, which will be used to create a personalized 3D model. This will be merged with a 3D photograph (taken at the start of the procedure) of the ECG electrodes on the subject’s torso. Then, the recording of the 12 lead ECG will be imported into the VIVO software. All of this data will be combined via the software and a mathematical algorithm will determine the origin of the arrhythmia. This will show the physician where to perform a successful ablation. After 3 months, the subject will return for follow up and receive another Holter monitor (ECG recording) to determine ablation success.
Subjects will be exited from the study after the 3 month follow up visit. Patients will receive standard clinical care prior to, during and after their scheduled procedure, as well as after being discarded from the trial.
REC name
London - Surrey Research Ethics Committee
REC reference
19/LO/0308
Date of REC Opinion
18 Apr 2019
REC opinion
Further Information Favourable Opinion