VIVO Mapping Protocol

VIVO Non-invasive Time Assessment 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

Study Overview

• Status: Unknown
• Conditions: Ventricular Tachycardia; Ventricular Ectopic Beat(S)
• Intervention / Treatment: Diagnostic test: VIVO non invasive mapping

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sabine Ernst, MD, PhD; Phone Number: 00442073518612; Email: s.ernst@rbht.nhs.uk
• Study Contact Backup: Name: Ilaria Cazzoli, MD; Email: I.Cazzoli@rbht.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VIVO mapping pre-procedure; 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.	Diagnostic test: VIVO non invasive mapping; non invasive pre-procedural localization of PVC / VT origin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	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.	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).	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
economical outcome: change of procedural costs	To assess economical outcome, which is meant as cost change (in pounds) per number of cases	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)	three months

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Sabine Ernst, MD, PhD, Royal Brompton and Harefield Hospital Trust; Study Chair: Ilaria Cazzoli, MD, Royal Brompton and Harefield Hospital Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: May 4, 2019
• First Submitted That Met QC Criteria: June 19, 2019
• First Posted (Actual): June 21, 2019

Study Record Updates

• Last Update Posted (Actual): June 21, 2019
• Last Update Submitted That Met QC Criteria: June 19, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cardiac Complexes, Premature; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: VIVO-RBH01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes