Premature Ventricular ContractionNCT03340142
VIVO™ Accuracy Study
A study testing VIVO™ in people with Premature Ventricular Contraction and Ventricular Tachycardia, run by Catheter Precision. Inc. at 3 sites in United States.
Trial summary
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Premature Ventricular Contraction, Ventricular Tachycardia
- What is being tested?
- VIVO™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Jan 2018to 1 Nov 2018
- 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 with structurally normal hearts and less than 10% scar.
- 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)
Who cannot join
- 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
- Active infection
- Pregnancy: Females of childbearing potential with a positive pregnancy test.
- Existing mechanical heart valve
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Unveristy
Baltimore, Maryland, 21287
Medical Unversity of South Carolina
Charleston, South Carolina, 29425
University of Iowa
Iowa City, Iowa, 52242
About this study
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.
Read the detailed description
The VIVO accuracy study will assess the accuracy of locating a PVC/VT foci by pacing known anatomical locations and comparing the VIVO outcome to that of the Carto system (Biosense-Webster).
- Being tested
- VIVO™
- Medical subject headings
- Ventricular Premature Complexes, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIVO™Device
Diagnose the area of a PVC or VT onset
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | All patients will undergo standard of care ablation procedures. VIVO™ results will be compared to that of standard of care results, but will not be used in diagnosis or treatment. Receives: Device: VIVO™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of correctly identifying PVC or VT origin
Determine the accuracy of VIVO in identifying a PVC/VT to the left or right ventricle or the septum. The origin, identified by VIVO, will be compared to the Carto system and the successful ablation location.
Measured: 1 Day
Secondary outcomes (2)
Accuracy of correctly identifying known pacing sites
Determine the accuracy of VIVO in identifying the location of known pacing sites as compared to the Carto system. The origin, identified by VIVO, will be compared to the location identified by Carto as well as the successful ablation location.
Measured: 1 Day
Number of adverse events
Monitor adverse events that occur during the procedure followed by a review from the CEC for correlation to VIVO and adjudication if appropriate.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start29 Jan 2018
- Primary completion4 Sep 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature Ventricular ContractionStudies 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
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catheter Precision. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Missiaen Huck, Study director, Catheter Precision. Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340142
- Sponsor's protocol ID
- 94-9001-004
- Status last verified
- Nov 2018
- First submitted
- 3 Nov 2017
- Last updated
- 15 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIVO™ Accuracy Study
- ClinicalTrials.gov ID
- NCT03340142
- Acronym / sponsor ID
- 94-9001-004
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Catheter Precision. Inc.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 4 Sep 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 13 Nov 2017 (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.
A multi-center study designed to assess the accuracy of VIVO™ in determining the location of a PVC/VT foci in comparison to an electroanatomical mapping system.
Detailed description
The VIVO accuracy study will assess the accuracy of locating a PVC/VT foci by pacing known anatomical locations and comparing the VIVO outcome to that of the Carto system (Biosense-Webster).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Device: VIVO™All patients will undergo standard of care ablation procedures. VIVO™ results will be compared to that of standard of care results, but will not be used in diagnosis or treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects who are at least 18 years or older
- Subjects who are scheduled for PVC/VT ablation procedure with structurally normal hearts and less than 10% scar.
- 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)
Key exclusion criteria (7 listed)
- 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
- Active infection
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™Diagnose the area of a PVC or VT onset | Device | Single Arm |
Primary outcome
Accuracy of correctly identifying PVC or VT origin
Time frame: 1 Day
Determine the accuracy of VIVO in identifying a PVC/VT to the left or right ventricle or the septum. The origin, identified by VIVO, will be compared to the Carto system and the successful ablation location.
2 secondary outcomes
Accuracy of correctly identifying known pacing sites
Time frame: 1 Day
Number of adverse events
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Premature Ventricular Contraction
Not yet recruitingObservational study
Premature Ventricular Complex and Diet Inflamatuar Index
Premature Ventricular Complexes, Diet Quality
RecruitingObservational study
AI-Based Differential Diagnosis and Localization of Tachycardia Using ECG: Multicenter Registry (EP-AI ASSIST)
Tachycardia, Paroxysmal Supraventricular Tachycardia
Recruiting
Disrupted Sleep and Concurrent Ectopy or Atrial Fibrillation
Obstructive Sleep Apnea, Premature Ventricular Contraction (PVC)
Recruiting
A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
Recruiting
Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes
Premature Ventricular Complexes, Premature Ventricular Contraction (PVC)
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.
Missiaen Huck study director
Catheter Precision. Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIVO™ in people with Premature Ventricular Contraction and Ventricular Tachycardia, run by Catheter Precision. Inc. at 3 sites in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 15 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of correctly identifying PVC or VT origin (time frame: 1 Day). 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 15 Nov 2018.