VIVO European Observational Registry

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.

Study Overview

• Status: Completed
• Conditions: Ventricular Tachycardia; Ventricular Arrythmia; Premature Ventricular Contraction
• Intervention / Treatment: Device: VIVO

• Study Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• Ireland
  • Dublin, Ireland
    • Mater Private Hospital
• Italy
  • Ascoli Piceno, Italy
    • Mazzoni Hospital
• Netherlands
  • Groningen, Netherlands
    • University Medical Center Groningen
  • Rotterdam, Netherlands
    • Erasmus Medical Center
• Portugal
  • Lisbon, Portugal
    • La Luz Hospital
• United Kingdom
  • Leicester, United Kingdom
    • Glenfield University Hospital
  • London, United Kingdom
    • Royal Brompton Hospital
  • Oxford, United Kingdom
    • John Radcliffe University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients experiencing ventricular tachycardia (VT) or premature ventricular contractions (PVC) and being considered for or have a scheduled a ventricular ablation procedure.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Patients that are unable to receive contrast cardiac imaging (MR or CT)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VIVO; Patients in which VIVO is used.	Device: VIVO; VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Collaborators and Investigators

• Sponsor: Catheter Precision. Inc.
• Investigators: Principal Investigator: Andre Ng, MD, Glenfield University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2021
• Primary Completion (Actual): June 28, 2024
• Study Completion (Actual): September 28, 2024

Study Registration Dates

• First Submitted: July 27, 2021
• First Submitted That Met QC Criteria: July 27, 2021
• First Posted (Actual): August 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Cardiac Complexes, Premature; Tachycardia; Tachycardia, Ventricular; Ventricular Premature Complexes
• Other Study ID Numbers: 02-0521-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: NO IPD is to be shared with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes