Clinical trial NCT03994068: VIVO Mapping Protocol
Official title: VIVO Non-invasive Time Assessment Protocol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Ectopic Beat(S)
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction of procedural time (in minutes)
timeFrame: three months
measure: Safety - absence of acute adverse events using VIVO system for non-invasive mapping
timeFrame: three months
measure: Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure
timeFrame: three months
Secondary outcomes:
measure: economical outcome: change of procedural costs
timeFrame: three months
measure: clinical outcome assessed as change of PVCs/VT burden
timeFrame: three months
Other outcomes:
Locations:
Study officials:
affiliation: Royal Brompton and Harefield Hospital Trust
name: Sabine Ernst, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brompton and Harefield Hospital Trust
name: Ilaria Cazzoli, MD
role: STUDY_CHAIR
References: