VIVO Mapping Protocol

Royal Brompton & Harefield NHS Foundation Trust15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Ventricular Tachycardia Ventricular Ectopic Beat(S)

Interventions

VIVO non invasive mappingDIAGNOSTIC_TEST

non invasive pre-procedural localization of PVC / VT origin

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Reduction of procedural time (in minutes)

Use of VIVO mapping to localize the PVC / VT origin prior to the catheter procedure in order to change procedural time. Procedural time is meant to be measured in minutes per procedure, and it is normally considered from "puncture time" to "sheaths removal".

Time frame: three months

Safety - absence of acute adverse events using VIVO system for non-invasive mapping

Absence of acute adverse events due to the use of VIVO system during PVC/VT ablation in the cohort of patients enrolled for the study. Acute adverse events are described in section 12 of the study protocol and will be reported in specific forms to the Sponsor and REC.

Time frame: three months

Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure

Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).

Time frame: three months

Secondary Outcomes

economical outcome: change of procedural costs

To assess economical outcome, which is meant as cost change (in pounds) per number of cases

Time frame: three months

clinical outcome assessed as change of PVCs/VT burden

Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)

Time frame: three months

Central Contacts

Sabine Ernst, MD, PhD

CONTACT

00442073518612 s.ernst@rbht.nhs.uk

Ilaria Cazzoli, MD

CONTACT

I.Cazzoli@rbht.nhs.uk

Data from ClinicalTrials.gov

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