Ventricular TachycardiaNCT03994068
VIVO Mapping Protocol
A study testing VIVO non invasive mapping in people with Ventricular Tachycardia and Ventricular Ectopic Beat(S), run by Royal Brompton & Harefield NHS Foundation Trust.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Ectopic Beat(S)
- What is being tested?
- VIVO non invasive mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2019to 31 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Active infection
- Pregnancy: Females of childbearing potential with a positive pregnancy test.
- Existing mechanical heart valve
- Subjects with structural cardiac disease
Trial locations and contacts
No sites are listed yet.
Ilaria Cazzoli, MD contact
About this study
Official title: 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
Read the 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.
- Being tested
- VIVO non invasive mapping
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVO non invasive mappingDiagnostic test
non invasive pre-procedural localization of PVC / VT origin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: VIVO non invasive mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: 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.
Measured: 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).
Measured: three months
Secondary outcomes (2)
economical outcome: change of procedural costs
To assess economical outcome, which is meant as cost change (in pounds) per number of cases
Measured: 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)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study startJun 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Ernst, MD, PhD, Principal investigator, Royal Brompton and Harefield Hospital TrustIlaria Cazzoli, MD, Study chair, Royal Brompton and Harefield Hospital Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03994068
- Sponsor's protocol ID
- VIVO-RBH01
- Status last verified
- Jun 2019
- First submitted
- 4 May 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIVO Non-invasive Time Assessment Protocol
- ClinicalTrials.gov ID
- NCT03994068
- Acronym / sponsor ID
- VIVO-RBH01
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Jun 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 21 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VIVO mapping pre-procedure | Experimental | Diagnostic Test: VIVO non invasive mapping15 patients with structurally normal heart and indication for PVC/VT catheter ablation, who will undergo pre-procedural non invasive mapping with VIVO mapping system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VIVO non invasive mappingnon invasive pre-procedural localization of PVC / VT origin | Diagnostic test | VIVO mapping pre-procedure |
Primary outcome
Reduction of procedural time (in minutes)
Time frame: three months
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
Time frame: three months
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
Time frame: three months
Safety endpoint of the entire mapping and ablation strategy, determined by the absence of adverse events (AEs).
2 secondary outcomes
economical outcome: change of procedural costs
Time frame: three months
clinical outcome assessed as change of PVCs/VT burden
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilaria Cazzoli, MD contact
Sabine Ernst, MD, PhD principal investigator
Royal Brompton and Harefield Hospital Trust
Ilaria Cazzoli, MD study chair
Royal Brompton and Harefield Hospital Trust
Questions about this trial
What is this clinical trial studying?
A study testing VIVO non invasive mapping in people with Ventricular Tachycardia and Ventricular Ectopic Beat(S), run by Royal Brompton & Harefield NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sabine Ernst, MD, PhD (00442073518612, s.ernst@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of procedural time (in minutes) (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.