VIVO European Observational Registry

Ventricular Tachycardia Clinical Trial

Official title:

VIVO in a Practical Clinical Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04990089
• Other study ID #: 02-0521-001
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2023

Study information

• Verified date: July 2021
• Source: Catheter Precision. Inc.
• Contact: Missiaen Huck
• Phone: 973-691-2000
• Email: mhuck[@]catheterprecision.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: September 1, 2023
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Premature Ventricular Contraction
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Arrythmia
• Ventricular Premature Complexes
• Ventricular Tachycardia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Catheter Precision. Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness	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.	1 day
Primary	Safety	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	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