VIVO Mapping Protocol
VIVO Mapping Protocol
This is a single centre 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. Results will be compared with data from
VIVO TM is a non invasive mapping system which can be used to localize PVC / VT origin prior
 to the ablative procedure.

 Subjects scheduled for catheter ablation with VIVO 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 will receive another ECG 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.

 Results will be analysed and compared to those from an historical cohort of patients (age /
 gender matched, undergone the same procedure) ablated by the same operator within the
 previous 5 years (from a database already collected). Data will be anonymised as per current
 regulations.
Inclusion Criteria:

 1. Subjects who are at least 18 years or older

 2. Subjects who are scheduled for PVC/VT ablation procedure

 3. Subjects who have signed an IRB/EC approved Informed Consent Form and applicable
 subject privacy protection authorization per local law

 4. Subjects will be selected without regard to gender or age (unless precluded by local
 regulatory requirements)

 5. Subjects with or without cardiac structural disease

 Exclusion Criteria:

 1. Reversible causes of PVC/VT

 2. Subjects with recent (within 3 months) acute coronary syndrome

 3. Subjects who are contraindicated for CT or MRI (must be able to get one)

 4. Subject whose MRI or CT scan does not comply with the requirements of this protocol

 5. Subjects who are contraindicated for an electrophysiology procedure and/or
 fluoroscopy:

 -  INR > 3.5

 -  Active infection

 -  Pregnancy: Females of childbearing potential with a positive pregnancy test.

 6. Existing mechanical heart valve

 7. Subjects with structural cardiac disease