VIVO European Observational Registry

Completed

• Conditions: Ventricular Tachycardia; Premature Ventricular Contraction; Ventricular Arrythmia
• Interventions: Device: VIVO

• Registration Number: NCT04990089
• Lead Sponsor: Catheter Precision. Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-27
• Study First Submitted QC: 2021-07-27
• Study First Posted: 2021-08-04
• Study Start: 2021-10-21
• Primary Completion: 2024-06-28
• Study Completion: 2024-09-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VIVO	VIVO	Patients in which VIVO is used.

Primary Outcome Measures

Name	Time	Method
Measure the effectiveness of VIVO within different types of VA procedures	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	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 Outcome Measures

Name	Time	Method
Effectiveness	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.

Trial Locations

Locations (8)

Mater Private Hospital; 🇮🇪 Dublin, Ireland

Mazzoni Hospital; 🇮🇹 Ascoli Piceno, Italy

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

La Luz Hospital; 🇵🇹 Lisbon, Portugal

Glenfield University Hospital; 🇬🇧 Leicester, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom

John Radcliffe University Hospital; 🇬🇧 Oxford, United Kingdom