VIVO Mapping Protocol

Royal Brompton & Harefield NHS Foundation Trust

Status: Unknown

Conditions: Ventricular Ectopic Beat(S); Ventricular Tachycardia

Treatments: Diagnostic Test: VIVO non invasive mapping

Study type: Interventional

Funder types: Other

Identifiers

NCT03994068

VIVO-RBH01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

15 participants in 1 patient group

VIVO mapping pre-procedure

Experimental group

Description:

15 patients with structurally normal heart and indication for PVC/VT catheter ablation, who will undergo pre-procedural non invasive mapping with VIVO mapping system.

Treatment:

Diagnostic Test: VIVO non invasive mapping