Ventricular ArrythmiaNCT04990089
VIVO European Observational Registry
An observational study of Ventricular Arrythmia and Ventricular Tachycardia, run by Catheter Precision. Inc. at 8 sites in 5 countries.
Trial summary
A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Arrythmia, Ventricular Tachycardia, Premature Ventricular Contraction
- What is being tested?
- VIVO
- Type of treatment
- Medical device
- How many people
- 125 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 21 Oct 2021to 28 Sep 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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
Study population: Patients experiencing ventricular tachycardia (VT) or premature ventricular contractions (PVC) and being considered for or have a scheduled a ventricular ablation procedure.
Who may be able to join
- Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law
- Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care
- Patients will be selected without regard to gender.
Who cannot join
- Patients that are unable to receive contrast cardiac imaging (MR or CT)
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
United Kingdom3 sites
Glenfield University Hospital
Leicester
Royal Brompton Hospital
London
John Radcliffe University Hospital
Oxford
Netherlands2 sites
University Medical Center Groningen
Groningen
Erasmus Medical Center
Rotterdam
About this study
Official title: VIVO in a Practical Clinical Experience
A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.
- Being tested
- VIVO
- 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.
VIVODevice
VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the effectiveness of VIVO within different types of VA procedures
The primary effectiveness objective is to assess the types of procedures where VIVO is used to plan and/or guide the ablation procedure or to determine a diagnosis of arrhythmia.
Primary Effectiveness endpoint: Summarize the types of procedures where VIVO was utilized in the procedure to include the number of VT vs PVC, whether VIVO improved procedural planning and acute procedural success measured as termination or reduction in arrhythmia.
Measured: 1 day
Measure the safety by observing adverse events related to the device and procedure
Primary safety objective is to assess any adverse events related to the device and procedure.
Primary Safety endpoint: Summarize the number of adverse events related to VIVO or procedure.
Measured: 1 day
Secondary outcomes (1)
Effectiveness
Secondary effectiveness objective is to evaluate the success of the ablation procedure (if performed) at follow- up visits (3, 6 and 12 months).
Secondary effectiveness endpoint: Summarize the success of the ablation procedure at each follow up visit.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start21 Oct 2021
- Primary completion28 Jun 2024
- Study completion28 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular ArrythmiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Catheter Precision. Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andre Ng, MD, Principal investigator, Glenfield University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990089
- Sponsor's protocol ID
- 02-0521-001
- Status last verified
- Jan 2025
- First submitted
- 27 Jul 2021
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: NO IPD is to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIVO in a Practical Clinical Experience
- ClinicalTrials.gov ID
- NCT04990089
- Acronym / sponsor ID
- 02-0521-001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Catheter Precision. Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 28 Sep 2024 (actual)
- First posted
- 4 Aug 2021 (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, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients experiencing ventricular tachycardia (VT) or premature ventricular contractions (PVC) and being considered for or have a scheduled a ventricular ablation procedure.
Key inclusion criteria (3 listed)
- Patients must at least 18 years of age Patients who have signed an IRB/EC approved patient informed consent and applicable patient privacy protection authorization per local law
- Patients who have previously had contrast cardiac imaging or will have cardiac imaging ordered per standard of care
- Patients will be selected without regard to gender.
Key exclusion criteria (1 listed)
- Patients that are unable to receive contrast cardiac imaging (MR or CT)
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 |
|---|---|---|
| VIVOVIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia. | Device | – |
Primary outcome
Measure the effectiveness of VIVO within different types of VA procedures
Time frame: 1 day
The primary effectiveness objective is to assess the types of procedures where VIVO is used to plan and/or guide the ablation procedure or to determine a diagnosis of arrhythmia. Primary Effectiveness endpoint: Summarize the types of procedures where VIVO was utilized in the procedure to include the number of VT vs PVC, whether VIVO improved procedural planning and acute procedural success measured as termination or reduction in arrhythmia.
Measure the safety by observing adverse events related to the device and procedure
Time frame: 1 day
Primary safety objective is to assess any adverse events related to the device and procedure. Primary Safety endpoint: Summarize the number of adverse events related to VIVO or procedure.
1 secondary outcome
Effectiveness
Time frame: 12 months
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 31 Jan 2025.
- Individual participant dataSharing planned: No. NO IPD is to be shared with other researchers.
Related trials for Ventricular Arrythmia
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VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
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EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
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A Study of Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter With the TRUPULSE™ Generator for Treatment of Ventricular Arrhythmias
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A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter
Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation
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.
Andre Ng, MD principal investigator
Glenfield University Hospital
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Arrythmia and Ventricular Tachycardia, run by Catheter Precision. Inc. at 8 sites in 5 countries.
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 3 inclusion and 1 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 31 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Netherlands, Ireland, Italy, Portugal. 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?
Measure the effectiveness of VIVO within different types of VA procedures (time frame: 1 day). The study lists 2 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 31 Jan 2025.