VIVO European Observational Registry

Catheter Precision. Inc.125 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

125

Conditions

Ventricular Arrythmia Ventricular Tachycardia Premature Ventricular Contraction

Interventions

VIVODEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (8)

Mater Private Hospital

Dublin, Ireland

Mazzoni Hospital

Ascoli Piceno, Italy

University Medical Center Groningen

Groningen, Netherlands

Erasmus Medical Center

Rotterdam, Netherlands

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 1 day

Secondary Outcomes

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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