VIVO Mapping Protocol
Primary Purpose
Ventricular Tachycardia, Ventricular Ectopic Beat(S)
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
VIVO non invasive mapping
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventricular Tachycardia
Eligibility Criteria
Inclusion Criteria:
- Subjects who are at least 18 years or older
- Subjects who are scheduled for PVC/VT ablation procedure
- Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
- Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
- Subjects with or without cardiac structural disease
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:
- INR > 3.5
- Active infection
- Pregnancy: Females of childbearing potential with a positive pregnancy test.
- Existing mechanical heart valve
- Subjects with structural cardiac disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VIVO mapping pre-procedure
Arm 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.
Outcomes
Primary Outcome Measures
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".
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.
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).
Secondary Outcome Measures
economical outcome: change of procedural costs
To assess economical outcome, which is meant as cost change (in pounds) per number of cases
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)
Full Information
NCT ID
NCT03994068
First Posted
May 4, 2019
Last Updated
June 19, 2019
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT03994068
Brief Title
VIVO Mapping Protocol
Official Title
VIVO Non-invasive Time Assessment Protocol
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ventricular Ectopic Beat(S)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VIVO mapping pre-procedure
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
VIVO non invasive mapping
Intervention Description
non invasive pre-procedural localization of PVC / VT origin
Primary Outcome Measure Information:
Title
Reduction of procedural time (in minutes)
Description
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
Title
Safety - absence of acute adverse events using VIVO system for non-invasive mapping
Description
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
Title
Safety 2 - absence of acute adverse events using VIVO system for mapping and during the whole ablation procedure
Description
Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).
Time Frame
three months
Secondary Outcome Measure Information:
Title
economical outcome: change of procedural costs
Description
To assess economical outcome, which is meant as cost change (in pounds) per number of cases
Time Frame
three months
Title
clinical outcome assessed as change of PVCs/VT burden
Description
Count of PVC/VT burden at 3-month follow up Holter (expressed as No. / 24 hours)
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects who are at least 18 years or older
Subjects who are scheduled for PVC/VT ablation procedure
Subjects who have signed an IRB/EC approved Informed Consent Form and applicable subject privacy protection authorization per local law
Subjects will be selected without regard to gender or age (unless precluded by local regulatory requirements)
Subjects with or without cardiac structural disease
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:
INR > 3.5
Active infection
Pregnancy: Females of childbearing potential with a positive pregnancy test.
Existing mechanical heart valve
Subjects with structural cardiac disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Ernst, MD, PhD
Phone
00442073518612
Email
s.ernst@rbht.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Cazzoli, MD
Email
I.Cazzoli@rbht.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Ernst, MD, PhD
Organizational Affiliation
Royal Brompton and Harefield Hospital Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilaria Cazzoli, MD
Organizational Affiliation
Royal Brompton and Harefield Hospital Trust
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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VIVO Mapping Protocol
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