VIVO European Observational Registry | Clinical Trial

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mater Private Hospital, Dublin, Ireland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

VIVO

Device

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

Primary outcomes

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.

Secondary outcomes

Effectiveness

Time frame: 12 months

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.

Sponsors and collaborators

Lead sponsor

Catheter Precision. Inc.

Industry

Registry information

Official study title

VIVO in a Practical Clinical Experience

Important dates

Study start: 2021
Primary completion: 2024
Study completion: 2024
First posted: Aug 4, 2021
Registry last updated: Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed