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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIVO mapping pre-procedure | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVO non invasive mapping | Diagnostic Test | non invasive pre-procedural localization of PVC / VT origin |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Reversible causes of PVC/VT
Subjects with recent (within 3 months) acute coronary syndrome
Subjects who are contraindicated for CT or MRI (must be able to get one)
Subject whose MRI or CT scan does not comply with the requirements of this protocol
Subjects who are contraindicated for an electrophysiology procedure and/or fluoroscopy:
Existing mechanical heart valve
Subjects with structural cardiac disease
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabine Ernst, MD, PhD | Contact | 00442073518612 | s.ernst@rbht.nhs.uk | |
| Ilaria Cazzoli, MD | Contact | I.Cazzoli@rbht.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Sabine Ernst, MD, PhD | Royal Brompton and Harefield Hospital Trust | Principal Investigator |
| Ilaria Cazzoli, MD | Royal Brompton and Harefield Hospital Trust | Study Chair |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 15, 2019 | Mar 31, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D018879 | Ventricular Premature Complexes |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)
| three months |
| D000075224 |
| Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005117 | Cardiac Complexes, Premature |