VIVO European Observational Registry

NCT04990089 | Completed DMC FDA Device

• 1 other identifier: 02-0521-001
• Study Type: observational
• Target: 125
• Locations: 5 countries
• Sites: 8

Brief Summary

A multi-center, observational registry conducted in Europe and the UK to prospectively review VIVO in a clinical setting in 125 patients.

Conditions

Ventricular Arrythmia; Ventricular Tachycardia; Premature Ventricular Contraction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Effectiveness

  12 months

Interventions

VIVO DEVICE

VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Catheter Precision. Inc.: lead

Study Sites (8)

Mater Private Hospital

Dublin, Ireland

Location

Mazzoni Hospital

Ascoli Piceno, Italy

Location

University Medical Center Groningen

Groningen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

La Luz Hospital

Lisbon, Portugal

Location

Glenfield University Hospital

Leicester, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

John Radcliffe University Hospital

Oxford, United Kingdom

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cardiac Complexes, Premature

Study Officials

• Andre Ng, MD

  Glenfield University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 4, 2021
• Study Start: October 21, 2021
• Primary Completion: June 28, 2024
• Study Completion: September 28, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); NL (2); IE (1); PT (1); GB (3)